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
3145–3168 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Feb 09, 1994
MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR
K933122 · JTY
Bioclinical Systems, Inc.
Microbiology · 229d
Cleared Feb 09, 1994
BACT/ALERT 120
K934593 · MDB
Organon Teknika Corp.
Microbiology · 138d
Cleared Feb 07, 1994
BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT
K933939 · GIM
Organon Teknika Corp.
Microbiology · 179d
Cleared Feb 03, 1994
MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR
K933121 · JTY
Bioclinical Systems, Inc.
Microbiology · 223d
Cleared Feb 03, 1994
IMMUNOCARD ROTAVIRUS
K933587 · LIQ
Meridian Diagnostics, Inc.
Microbiology · 192d
Cleared Jan 27, 1994
PASCO MIC PANELS/ GENT & STREP SYNERGY
K934380 · JWY
Pasco Laboratories, Inc.
Microbiology · 141d
Cleared Dec 27, 1993
IDEIA(TM) ROTAVIRUS
K932384 · LIQ
Dako Diagnostics , Ltd.
Microbiology · 224d
Cleared Dec 27, 1993
PASCO MIC AND MIC/ID PANELS
K933709 · JWY
Pasco Laboratories, Inc.
Microbiology · 150d
Cleared Dec 27, 1993
PASCO MIC AND MIC/ID PANELS
K933746 · JWY
Pasco Laboratories, Inc.
Microbiology · 146d
Cleared Dec 22, 1993
DRYSLIDE CEFIN
K930702 · JTN
Difco Laboratories, Inc.
Microbiology · 315d
Cleared Dec 21, 1993
THAYER MARTIN, MODIFIED PILL POCKET
K934331 · JTY
Hardy Diagnostics
Microbiology · 109d
Cleared Dec 17, 1993
TRANSGROW
K934330 · JTY
Hardy Diagnostics
Microbiology · 105d
Cleared Dec 15, 1993
MARTIN LEWIS WITH LINOCMYCIN
K931864 · JTY
Hardy Diagnostics
Microbiology · 245d
Cleared Dec 15, 1993
PYR TEST KIT
K931865 · JTO
Hardy Diagnostics
Microbiology · 245d
Cleared Dec 02, 1993
STREP A NEGATIVE CONTROL
K924461 · GTZ
Pacific Biotech, Inc.
Microbiology · 456d
Cleared Dec 02, 1993
PARAPREP
K931849 · LKS
Medastat Scientific Corp.
Microbiology · 233d
Cleared Nov 22, 1993
PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY
K933997 · GMD
Alexon Biomedical, Inc.
Microbiology · 97d
Cleared Nov 22, 1993
REMEL CEFPROZIL 30 MCG SUSCEPTIBILITY DISK
K934100 · JTN
Remel Co.
Microbiology · 91d
Cleared Nov 16, 1993
PASCO MIC AND MIC/ID PANELS
K933849 · JWY
Pasco Laboratories, Inc.
Microbiology · 103d
Cleared Nov 16, 1993
ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K933885 · JWY
Alamar Biosciences, Inc.
Microbiology · 98d
Cleared Nov 05, 1993
ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS
K931443 · LSE
Ortho Diagnostic Systems, Inc.
Microbiology · 228d
Cleared Nov 05, 1993
VISI-SPOT
K932752 · JTO
J.S. Medical Assoc.
Microbiology · 170d
Cleared Oct 28, 1993
BACTICARD STREP
K933514 · JTO
Remel Co.
Microbiology · 100d
Cleared Oct 28, 1993
REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK
K933657 · JTN
Remel Co.
Microbiology · 93d