FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Microbiology ×
7,067 results
2065–2088 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 21, 2000
DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM
K001875 · LFX
Diamedix Corp.
Microbiology · 62d
Cleared Aug 10, 2000
PASCO MIC AND MIC/ID PANELS
K001953 · JWY
Pasco Laboratories, Inc.
Microbiology · 44d
Cleared Aug 09, 2000
MODIFICATION TO PASCO MIC AND MIC/ID PANELS
K001887 · JWY
Pasco Laboratories, Inc.
Microbiology · 49d
Cleared Aug 07, 2000
ETEST ESBL CT/CTL STRIP
K001547 · JWY
Ab Biodisk
Microbiology · 81d
Cleared Aug 07, 2000
DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM
K001767 · LJO
Diamedix Corp.
Microbiology · 56d
Cleared Aug 04, 2000
PASCO MIC AND MIC/ID PANELS
K001721 · LTT
Pasco Laboratories, Inc.
Microbiology · 59d
Cleared Jul 27, 2000
HARDY DISK CLARITHROMYCIN, 15MCG
K001728 · JTN
Hardy Diagnostics
Microbiology · 50d
Cleared Jul 24, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (QUINUPRISTIN/DALFOPRISTIN)
K001558 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 66d
Cleared Jul 18, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES
K001573 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 57d
Cleared Jul 18, 2000
PASCO MIC AND MIC/ID PANELS
K001612 · JWY
Pasco Laboratories, Inc.
Microbiology · 54d
Cleared Jul 12, 2000
PASCO MIC AND MIC/ID PANELS
K001516 · JWY
Pasco Laboratories, Inc.
Microbiology · 57d
Cleared Jul 07, 2000
DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM
K001707 · LGD
Diamedix Corp.
Microbiology · 32d
Cleared Jun 28, 2000
BD DIRECTIGEN FLU A+B
K001364 · PSZ
Bd Becton Dickinson Vacutainer...
Microbiology · 58d
Cleared Jun 12, 2000
THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST
K000687 · GMQ
Beacon Biologicals, Inc.
Microbiology · 104d
Cleared Jun 07, 2000
HARDYDISK CINOXACIN, 100 MCG
K001487 · JTN
Hardy Diagnostics
Microbiology · 26d
Cleared Jun 06, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)
K001036 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 67d
Cleared Jun 01, 2000
IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG
K000463 · LYR
Diagnostic Products Corp.
Microbiology · 111d
Cleared Jun 01, 2000
HARDYDISK CEFOPERAZONE, 75 MCG
K001489 · JTN
Hardy Diagnostics
Microbiology · 20d
Cleared Jun 01, 2000
HARDYDISK CEFONICID, 30 MCG
K001490 · JTN
Hardy Diagnostics
Microbiology · 20d
Cleared May 23, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)
K001035 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 53d
Cleared May 22, 2000
ETEST GATIFLOXACIN
K000596 · JWY
Ab Biodisk
Microbiology · 90d
Cleared May 22, 2000
GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K000930 · JTN
Oxoid , Ltd.
Microbiology · 61d
Cleared May 22, 2000
VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210
K993319 · LGD
bioMerieux, Inc.
Microbiology · 231d
Cleared May 18, 2000
ETEST MOXIFLOXACIN
K000298 · JWY
Ab Biodisk
Microbiology · 108d