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
4249–4272 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Mar 01, 1988
VIROGEN CMV ANTIBODY TEST
K875101 · LQO
Wampole Laboratories
Microbiology · 82d
Cleared Mar 01, 1988
MODIFIED GROUP A STREPTOCOCCUS DETECTION KIT
K880665 · GTZ
Allelix Diagnostics, Inc.
Microbiology · 12d
Cleared Feb 24, 1988
IMAGEN INFLUENZA VIRUS A AND B TESTMI
K872958 · GNX
Boots-Celltech Diagnostics, Inc.
Microbiology · 210d
Cleared Feb 24, 1988
ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST
K873082 · GOD
Cambridge Bioscience Corp.
Microbiology · 203d
Cleared Feb 24, 1988
ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST
K873312 · GOD
Cambridge Bioscience Corp.
Microbiology · 190d
Cleared Feb 24, 1988
VIRGO(TM) MEASLES IGG ELISA
K873925 · LJB
Electro-Nucleonics Laboratories, Inc.
Microbiology · 152d
Cleared Feb 24, 1988
EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001
K880029 · KFH
Immuno-Mycologics, Inc.
Microbiology · 50d
Cleared Feb 19, 1988
RAPID COLORIMETRIC DIRECT STREP A TEST
K874761 · GTZ
New Horizons Diagnostics Co.
Microbiology · 92d
Cleared Feb 18, 1988
DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT
K872632 · GQN
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 227d
Cleared Feb 18, 1988
PRECEPT(TM) CIPROFLOXACIN
K874727 · JWY
Austin Biological Laboratories
Microbiology · 92d
Cleared Feb 18, 1988
MICROTRAK HSV CULTURE IDENTIFICATION TEST
K880436 · GQN
Syva Co.
Microbiology · 16d
Cleared Feb 16, 1988
RAMP HERPES SIMPLEX VIRUS (HSV) (CCT)
K874863 · GQN
Monoclonal Antibodies, Inc.
Microbiology · 83d
Cleared Feb 05, 1988
BIOTIS (TM) HAEMOPHILUS DUCREYI
K874176 · JSJ
Otisville Biopharm, Inc.
Microbiology · 115d
Cleared Feb 04, 1988
V-TREND RPRL CARD TEST
K875180 · GMP
Texas Immunology, Inc.
Microbiology · 49d
Cleared Feb 04, 1988
MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST
K880157 · GON
Syva Co.
Microbiology · 22d
Cleared Jan 28, 1988
BIOTIS (TM) SABHI (DOUBLE POUR)
K874179 · KZI
Otisville Biopharm, Inc.
Microbiology · 107d
Cleared Jan 27, 1988
BITEK(TM) BLOOD CULTURE SYSTEM
K875259 · JSG
Definitive Diagnostics, Inc.
Microbiology · 36d
Cleared Jan 27, 1988
WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER
K875275 · JTQ
Sterling Drug, Inc.
Microbiology · 34d
Cleared Jan 27, 1988
BREWER GEL FOR ANAEROBES
K875362 · KZJ
Fairleigh Dickinson Laboratories, Inc.
Microbiology · 27d
Cleared Jan 22, 1988
BITEK(TM) BLOOD CULTURE SYSTEM
K875273 · JSG
Definitive Diagnostics, Inc.
Microbiology · 29d
Cleared Jan 12, 1988
COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750
K875136 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 28d
Cleared Jan 11, 1988
IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530
K872942 · LKQ
Clinical Sciences, Inc.
Microbiology · 168d
Cleared Jan 11, 1988
GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL
K874876 · JWY
Baxter Healthcare Corp
Microbiology · 42d
Cleared Jan 05, 1988
EBV-EA TEST
K872617 · LSE
Gull Laboratories, Inc.
Microbiology · 183d