Medical Device Manufacturer · US , San Diego , CA

Gen-Probe, Inc.

62 submissions · 62 cleared · Since 1985
62
Total
62
Cleared
0
Denied

Gen-Probe, Inc. — FDA 510(k) Submissions

Gen-Probe, Inc. has submitted 62 FDA 510(k) premarket notifications since 1985, of which 62 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dna-reagents, Neisseria, Dna-reagents, Mycobacterium Spp., Dna Probe, Nucleic Acid Amplification, Chlamydia, Dna-reagents, Chlamydia, Colorimeter, Photometer, Spectrophotometer For Clinical Use . Use the specialty filter in the sidebar to narrow results.

62 devices
1–25 of 62
APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER
K122062 · OUY Trichomonas Vaginalis... · Microbiology
Jan 2013 180d
APTIMA COMBO 2 ASSAY
K111409 · LSL Dna-reagents, Neisseria · Microbiology
May 2012 350d
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091
K063664 · LSL Dna-reagents, Neisseria · Microbiology
Jan 2007 48d
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199
K063451 · MKZ Dna Probe, Nucleic Acid... · Microbiology
Jan 2007 68d
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091
K062440 · LSL Dna-reagents, Neisseria · Microbiology
Nov 2006 78d
APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM
K061413 · MKZ Dna Probe, Nucleic Acid... · Microbiology
Oct 2006 144d
TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196
K061509 · LSL Dna-reagents, Neisseria · Microbiology
Oct 2006 125d
TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY
K060652 · LSL Dna-reagents, Neisseria · Microbiology
Aug 2006 157d
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088
K053446 · MKZ Dna Probe, Nucleic Acid... · Microbiology
Jul 2006 225d
GEN-PROBE APTIMA COMBO 2 ASSAY
K043224 · LSL Dna-reagents, Neisseria · Microbiology
Aug 2005 260d
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE
K043144 · LSL Dna-reagents, Neisseria · Microbiology
Mar 2005 119d
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS
K043072 · MKZ Dna Probe, Nucleic Acid... · Microbiology
Jan 2005 80d
GEN-PROBE APTIMA COMBO 2 ASSAY
K032554 · LSL Dna-reagents, Neisseria · Microbiology
Dec 2003 134d
TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS
K032194 · LSL Dna-reagents, Neisseria · Microbiology
Dec 2003 159d
GEN-PROBE APTIMA COMBO 2 ASSAY
K022874 · JTW System, Transport, Aerobic · Microbiology
Sep 2002 53d
GEN-PROBE APTIMA COMBO 2 ASSAY
K003395 · LSL Dna-reagents, Neisseria · Microbiology
May 2001 201d
GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT
K962217 · MKZ Dna Probe, Nucleic Acid... · Microbiology
Nov 1996 170d
GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR
K940979 · LSL Dna-reagents, Neisseria · Microbiology
Oct 1994 244d
PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY
K920301 · LSL Dna-reagents, Neisseria · Microbiology
Apr 1994 826d
PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY
K920302 · LSK Dna-reagents, Chlamydia · Microbiology
Apr 1994 806d
GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST
K924715 · MDK Dna-probe, Reagents,... · Microbiology
Mar 1994 536d
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE
K921435 · LQF Dna-reagents,... · Microbiology
Jul 1992 120d
PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS
K920378 · LSK Dna-reagents, Chlamydia · Microbiology
Apr 1992 91d
ACCUPACE GROUP A STREPTOCOCCUS ID TEST
K915852 · MDK Dna-probe, Reagents,... · Microbiology
Apr 1992 97d
GEN-PROBE LUMINOMETER-LEADER 450
K905762 · JJQ Colorimeter, Photometer,... · Chemistry
Jan 1991 27d
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