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
2905–2928 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 12, 1995
POLIOVIRUS 2 MONOCLONAL ANTIBODY
K940034 · GOE
Light Diagnostics
Microbiology · 616d
Cleared Sep 12, 1995
ENTEROVIRUS 71 MONOCLONAL ANTIBODY
K940473 · GOE
Chemicon Intl., Inc.
Microbiology · 587d
Cleared Sep 08, 1995
ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS
K936073 · GNM
Chemicon Intl., Inc.
Microbiology · 627d
Cleared Sep 08, 1995
COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY
K936089 · GNM
Chemicon Intl., Inc.
Microbiology · 626d
Cleared Sep 08, 1995
COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY
K936145 · GNM
Chemicon Intl., Inc.
Microbiology · 620d
Cleared Sep 08, 1995
COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY
K936251 · GNM
Light Diagnostics
Microbiology · 617d
Cleared Sep 08, 1995
COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY
K936252 · GNM
Light Diagnostics
Microbiology · 617d
Cleared Sep 08, 1995
COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY
K936253 · GNM
Light Diagnostics
Microbiology · 617d
Cleared Sep 08, 1995
COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY
K936254 · GNM
Light Diagnostics
Microbiology · 617d
Cleared Sep 08, 1995
POLIOVIRUS 1 MONOCLONAL ANTIBODY
K940018 · GOE
Light Diagnostics
Microbiology · 612d
Cleared Sep 08, 1995
ENTEROVIRUS 70 MONCLONAL ANTIBODY
K940363 · GOE
Light Diagnostics
Microbiology · 590d
Cleared Sep 08, 1995
COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES
K940471 · GNM
Chemicon Intl., Inc.
Microbiology · 583d
Cleared Sep 08, 1995
COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY
K940472 · GNM
Chemicon Intl., Inc.
Microbiology · 583d
Cleared Sep 08, 1995
MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION)
K952873 · GTZ
Medix Biotech, Inc.
Microbiology · 94d
Cleared Aug 30, 1995
QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU
K935475 · GTZ
Syntron Bioresearch, Inc.
Microbiology · 653d
Cleared Aug 30, 1995
QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY
K935554 · GTZ
Syntron Bioresearch, Inc.
Microbiology · 651d
Cleared Aug 24, 1995
VZV IGG ELISA TEST
K941046 · LFY
Gull Laboratories, Inc.
Microbiology · 535d
Cleared Aug 24, 1995
LYFO(TM) DIFFERENTIAL DISK
K951889 · JTO
Microbiologics, Inc.
Microbiology · 122d
Cleared Aug 23, 1995
EBV LGG ELISA TEST
K941198 · LSE
Gull Laboratories, Inc.
Microbiology · 527d
Cleared Aug 21, 1995
SALIVA SAMPLER
K942435 · PJD
Saliva Diagnostic Systems, Inc.
Microbiology · 458d
Cleared Aug 15, 1995
RUBELISA (RUBESTAT)
K950227 · LFX
Bio-Whittaker, Inc., A Cambrex Co.
Microbiology · 217d
Cleared Aug 15, 1995
PIPERACILIN TAZOBACTAM 4 UG
K953223 · JWY
Ab Biodisk
Microbiology · 123d
Cleared Aug 14, 1995
ABBOTT TEST PACK STREP A TEST
K945571 · GTZ
Abbott Laboratories
Microbiology · 280d
Cleared Aug 04, 1995
RUBELLA IGG ELISA TEST
K941624 · LFX
Gull Laboratories, Inc.
Microbiology · 487d