Medical Device Manufacturer · US , St. Cloud , MN

Microbiologics, Inc.

18 submissions · 18 cleared · Since 1995
18
Total
18
Cleared
0
Denied

Microbiologics, Inc. — FDA 510(k) Submissions

Microbiologics, Inc. has submitted 18 FDA 510(k) premarket notifications since 1995, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays, Discs, Strips And Reagents, Microorganism Differentiation, Kit, Anaerobic Identification . Use the specialty filter in the sidebar to narrow results.

18 devices
1–18 of 18
Cepheid Xpert Respiratory Control Panel
K190086 · PMN Assayed External Control... · Microbiology
Oct 2019 263d
Cepheid Xpert SA Nasal Complete Control Panel
K191168 · PMN Assayed External Control... · Microbiology
Jun 2019 55d
Cepheid Xpert MRSA NxG Control Panel
K191172 · PMN Assayed External Control... · Microbiology
Jun 2019 50d
Cepheid Xpert CT/NG Control Panel
K190223 · PMN Assayed External Control... · Microbiology
May 2019 92d
Cepheid Xpert C. difficile/Epi Control Panel
K190463 · PMN Assayed External Control... · Microbiology
Apr 2019 52d
Cepheid Xpert GBS LB Control Panel
K182472 · PMN Assayed External Control... · Microbiology
Nov 2018 59d
BD MAX CT/GC/TV 20-Day QC Panel
K181683 · PMN Assayed External Control... · Microbiology
Aug 2018 63d
BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel
K181711 · PMN Assayed External Control... · Microbiology
Aug 2018 48d
LYFO(TM) DIFFERENTIAL DISK-BACITRACIN
K970009 · JTO Discs, Strips And... · Microbiology
Feb 1997 35d
LYFO(TM) DIFFERIENTAL DISK-PYR
K954812 · JTO Discs, Strips And... · Microbiology
Dec 1995 62d
LYFO(TM) DIFFERENTIAL DISK
K951889 · JTO Discs, Strips And... · Microbiology
Aug 1995 122d
LYFO(TM) DIFFERENTIAL DISK
K945487 · JSP Kit, Anaerobic... · Microbiology
May 1995 184d
LYFO(TM) DIFFERENTIAL DISK
K945488 · JSP Kit, Anaerobic... · Microbiology
May 1995 184d
LYFO(TM) DIFFERENTIAL DISK
K945489 · JSP Kit, Anaerobic... · Microbiology
May 1995 184d
LYFO(TM) DIFFERENTIAL DISK-SPS
K945880 · JTO Discs, Strips And... · Microbiology
Apr 1995 144d
LYFO(TM) DIFFERENTIAL DISK-STERILE DISK
K945881 · JTO Discs, Strips And... · Microbiology
Apr 1995 144d
LYFO(TM) DIFFERENTIAL DISK-BILE
K945882 · JTO Discs, Strips And... · Microbiology
Apr 1995 144d
LYFO(TM) DIFFERENTIAL DISK-BILE ESCULIN
K945883 · JTO Discs, Strips And... · Microbiology
Apr 1995 144d
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