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
3481–3504 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Aug 07, 1991
IDEIA(TM) CHLAMYDIA, MODIFICATION
K911430 · LIC
Novo Nordisk Diagnostics, Ltd.
Microbiology · 132d
Cleared Aug 07, 1991
GROUP A STREP POSITIVE AND NEGATIVE CONTROLS
K912868 · GTZ
Quidel Corp.
Microbiology · 40d
Cleared Jul 30, 1991
CYTOCLONE A & B EIA
K911958 · LLH
Cambridge Biotech Corp.
Microbiology · 88d
Cleared Jul 30, 1991
BACTI-SWAB(TM) II
K912831 · LIO
Remel Co.
Microbiology · 34d
Cleared Jul 26, 1991
RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA
K910304 · LQL
Vitek Systems, Inc.
Microbiology · 183d
Cleared Jul 24, 1991
CROMATEST SYPHILIS DIAGNOSTIC
K904496 · GMQ
Biotrax, Inc.
Microbiology · 295d
Cleared Jul 24, 1991
ICON STREP B IMMUNOENZYMETRIC ASSAY
K911417 · GTZ
Hybritech, Inc.
Microbiology · 114d
Cleared Jul 24, 1991
OLYMPUS PK TP(TM) SYSTEM, MODIFICATION
K911640 · GMT
Olympus Corp.
Microbiology · 107d
Cleared Jul 24, 1991
MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA
K912408 · MHI
Meridian Diagnostics, Inc.
Microbiology · 54d
Cleared Jul 24, 1991
FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS
K912488 · LSE
Immuno Concepts, Inc.
Microbiology · 50d
Cleared Jul 24, 1991
COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS
K912489 · LSE
Immuno Concepts, Inc.
Microbiology · 50d
Cleared Jul 22, 1991
ANTIGENZ CHLAMYDIA
K912680 · LJC
Baxter Diagnostics, Inc.
Microbiology · 49d
Cleared Jul 17, 1991
VZV IGM TEST
K911301 · GQX
Gull Laboratories, Inc.
Microbiology · 114d
Cleared Jul 17, 1991
BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT
K912150 · GTQ
Beckman Instruments, Inc.
Microbiology · 63d
Cleared Jul 01, 1991
NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)
K904499 · KFG
Ackrad Laboratories
Microbiology · 273d
Cleared Jul 01, 1991
ARD(TM) ANTIMICROBIAL REMOVAL DEVICE
K911771 · LJK
Bd Becton Dickinson Vacutainer...
Microbiology · 73d
Cleared Jun 28, 1991
LYME DISEASE IGM ELISA
K900206 · LSR
Hillcrest Biologicals
Microbiology · 528d
Cleared Jun 28, 1991
STAINING SYSTEM FOR PNEUMOCYSTIS CARINII
K905504 · LYF
Dako Corp.
Microbiology · 203d
Cleared Jun 24, 1991
CROATEST (R) RHEUMATOID DIAGNOSTIC
K904416 · GTQ
Biotrax, Inc.
Microbiology · 270d
Cleared Jun 24, 1991
VISUWELL SYPHILIS ANTIGEN
K910487 · LIP
Adi Diagnostics, Inc.
Microbiology · 138d
Cleared Jun 24, 1991
COLOR VUE TM- MYCOPLASMA PNEUMONIAE
K910833 · GSA
Seradyn, Inc.
Microbiology · 117d
Cleared Jun 24, 1991
VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED
K911429 · LQM
Vitek Systems, Inc.
Microbiology · 90d
Cleared Jun 24, 1991
FASTTECH SYSTEM 1
K911496 · LSR
3M Diagnostic Systems, Inc.
Microbiology · 81d
Cleared Jun 21, 1991
LYME IGM ELISA TEST
K903013 · LSR
Gull Laboratories, Inc.
Microbiology · 345d