Medical Device Manufacturer · US , Westwood , MA

Pb Diagnostic Systems, Inc.

35 submissions · 35 cleared · Since 1988
35
Total
35
Cleared
0
Denied

Pb Diagnostic Systems, Inc. — FDA 510(k) Submissions

Pb Diagnostic Systems, Inc. has submitted 35 FDA 510(k) premarket notifications since 1988, of which 35 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Fluorometer, For Clinical Use, Visual, Pregnancy Hcg, Prescription Use, Igd, Rhodamine, Antigen, Antiserum, Control, Enzyme Immunoassay, Theophylline, Radioimmunoassay, Free Thyroxine . Use the specialty filter in the sidebar to narrow results.

35 devices
1–25 of 35
OPUS FT4 TEST SYSTEM
K940507 · CEC Radioimmunoassay, Free... · Chemistry
Jul 1994 176d
OPUS PROCAINAMIDE TEST SYSTEM
K934762 · LAR Enzyme Immunoassay,... · Toxicology
Jul 1994 289d
OPUS CMV-G
K933389 · LFZ Enzyme Linked... · Microbiology
Jun 1994 351d
OPUS(R) SEROLOGY CONTROLS, MODIFICATION
K934137 · MJX Kit, Serological,... · Microbiology
Mar 1994 194d
OPUS DIGITOXIN
K935229 · DPG Radioimmunoassay,... · Toxicology
Dec 1993 51d
OPUS NAPA
K934705 · LAN Enzyme Immunoassay,... · Toxicology
Nov 1993 53d
OPUS ESTRADIOL
K933066 · CHP Radioimmunoassay, Estradiol · Chemistry
Sep 1993 78d
OPUS TOTAL CK
K933675 · CGS Nad Reduction/nadh... · Chemistry
Sep 1993 42d
OPUS(R) TOTAL B-HCG TEST SYSTEM
K932279 · JHI Visual, Pregnancy Hcg,... · Chemistry
Jul 1993 57d
OPUS MAGNUM ANALYZER
K926131 · KHO Fluorometer, For Clinical... · Chemistry
Jun 1993 182d
OPUS(R) VANCOMYCIN
K924957 · LEH Radioimmunoassay, Vancomycin · Toxicology
Dec 1992 72d
OPUS(R) CK-MB
K924429 · JHY Colorimetric Method, Cpk... · Toxicology
Oct 1992 44d
OPUS FERRITIN TEST SYSTEM
K915838 · DGE Igd, Rhodamine, Antigen,... · Immunology
Mar 1992 85d
OPUS MYOGLOBIN TEST SYSTEM
K915850 · DDR Myoglobin, Antigen,... · Immunology
Mar 1992 82d
OPUS(R) LH TEST SYSTEM
K913938 · CEP Radioimmunoassay,... · Toxicology
Nov 1991 65d
OPUS(R) PLUS ANALYZER
K913295 · JJQ Colorimeter, Photometer,... · Chemistry
Sep 1991 49d
OPUS(R) PROLACTIN TEST SYSTEM
K913280 · CFT Radioimmunoassay,... · Toxicology
Aug 1991 23d
OPUS(R) ROZO
K911834 · LGD Enzyme Linked... · Immunology
Aug 1991 109d
OPUS(R) TOBRAMYCIN
K911940 · LCR Fluorescent Immunoassay,... · Toxicology
Jul 1991 61d
OPUS CMV TEST SYSTEM
K905257 · LIN Antisera, Conjugated... · Microbiology
Apr 1991 147d
OPUS FSH
K911409 · CGJ Radioimmunoassay,... · Toxicology
Apr 1991 15d
OPUS GENTAMICIN
K905721 · LCQ Fluorescent Immunoassay... · Toxicology
Feb 1991 62d
OPUS T3 TEST SYSTEM
K905410 · CDP Radioimmunoassay, Total... · Toxicology
Feb 1991 63d
OPUS TM T-UPTAKE TEST SYSTEM
K902797 · KHQ Radioassay,... · Chemistry
Jul 1990 34d
OPUS TSH TEST SYSTEM
K902333 · JLW Radioimmunoassay,... · Chemistry
Jul 1990 42d
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