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
2425–2448 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 11, 1997
ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL
K974261 · LJK
Boston Biomedica, Inc.
Microbiology · 28d
Cleared Dec 02, 1997
QUANTA LITE TOXOPLASMA IGG
K971441 · LGD
Inova Diagnostics, Inc.
Microbiology · 228d
Cleared Dec 02, 1997
BACT/ALERT FAN CULTURE BOTTLES
K973325 · MDB
Organon Teknika Corp.
Microbiology · 89d
Cleared Dec 01, 1997
QUANTA LITE CMV IGG ELISA
K971335 · LFZ
Inova Diagnostics, Inc.
Microbiology · 235d
Cleared Dec 01, 1997
CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973479 · JTN
Oxoid , Ltd.
Microbiology · 77d
Cleared Nov 18, 1997
ELVIS HSV ID/TYPING TEST SYSTEM
K971662 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 203d
Cleared Nov 17, 1997
BACT/ALERT CULTURE BOTTLES
K973305 · MDB
Organon Teknika Corp.
Microbiology · 75d
Cleared Nov 14, 1997
PASCO MIC AND MIC/ID PANELS
K973317 · LTT
Pasco Laboratories, Inc.
Microbiology · 72d
Cleared Nov 13, 1997
SERODIA TP-PA
K971502 · GMT
Scimedx Tekfile Services
Microbiology · 203d
Cleared Nov 05, 1997
SERAQUEST VZV IGG
K972295 · LFY
Quest Intl., Inc.
Microbiology · 139d
Cleared Nov 05, 1997
PASCO MIC AND MIC/ID PANELS
K973695 · JWY
Pasco Laboratories, Inc.
Microbiology · 40d
Cleared Nov 04, 1997
MUMPS IGG ELISA TESTY
K971857 · LJY
Gull Laboratories, Inc.
Microbiology · 168d
Cleared Oct 29, 1997
THE MERETEK UBT BREATH TEST FOR H.PYLORI
K972352 · MSQ
Meretek Diagnostics, Inc.
Microbiology · 127d
Cleared Oct 22, 1997
TOXOPLASMA IGM ASSAY FOR THE BAYER IMMUNO1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K971989 · LGD
Bayer Corp.
Microbiology · 146d
Cleared Oct 21, 1997
SERAQUEST TOXOPLASMA IGM
K971672 · LGD
Quest Intl., Inc.
Microbiology · 167d
Cleared Oct 16, 1997
QUIX RAPID E. COLI O157 STRIP TEST
K972156 · GMZ
Guardian Scientific, Corp.
Microbiology · 129d
Cleared Oct 10, 1997
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K972799 · LTT
Dade Microscan, Inc.
Microbiology · 74d
Cleared Oct 10, 1997
LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973488 · JTN
Oxoid , Ltd.
Microbiology · 25d
Cleared Oct 10, 1997
LORACARBEF ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973489 · JTN
Oxoid , Ltd.
Microbiology · 25d
Cleared Oct 08, 1997
SNAP SWAB CULTURE COLLECTION AND TRANSPORT SYSTEM
K972726 · JSM
Medical Packaging Corp.
Microbiology · 79d
Cleared Oct 08, 1997
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
K972986 · MJX
Boston Biomedica, Inc.
Microbiology · 58d
Cleared Oct 06, 1997
CEFPODOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973487 · JTN
Oxoid , Ltd.
Microbiology · 21d
Cleared Oct 03, 1997
VIDAS ROTAVIRUS (RTV) ASSAY
K972895 · LIQ
Biomerieux Vitek, Inc.
Microbiology · 59d
Cleared Sep 25, 1997
FRESH CELLS VERO
K973209 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 29d