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
4105–4128 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Apr 25, 1988
PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS
K881277 · LSL
Gen-Probe, Inc.
Microbiology · 38d
Cleared Apr 21, 1988
SERODOT TOXOPLASMA IGG TEST KIT
K875363 · LGD
Disease Detection International, Inc.
Microbiology · 112d
Cleared Apr 21, 1988
PHARMACIA B2-MICRO RIA
K880719 · JZG
Pharmacia, Inc.
Microbiology · 58d
Cleared Apr 21, 1988
ACID FAST BACILLI HISTOLOGY CONTROL SLIDES
K881106 · LJG
Sigma Diagnostics, Inc.
Microbiology · 37d
Cleared Apr 21, 1988
SPIROCHETES HISTOLOGY CONTROL SLIDES
K881109 · LJG
Sigma Diagnostics, Inc.
Microbiology · 37d
Cleared Apr 21, 1988
FUNGI HISTOLOGY CONTROL SLIDES
K881112 · LJG
Sigma Diagnostics, Inc.
Microbiology · 37d
Cleared Apr 21, 1988
KODAK SURECELL STREP A TEST KIT
K881457 · GTZ
Eastman Kodak Company
Microbiology · 15d
Cleared Apr 21, 1988
MODIFIED PARACON(TM) CONCENTRATION KIT
K881649 · LKS
Para Scientific Co.
Microbiology · 6d
Cleared Apr 19, 1988
MICROTRAK CMV CULTURE CONFIRMATION TEST
K880290 · GQH
Syva Co.
Microbiology · 85d
Cleared Apr 18, 1988
DNASE TEST AGAR
K881486 · JSH
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
DEXTROSE AGAR
K881522 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
DEXTROSE TRYPTONE BROTH
K881523 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
DERMATOPHYTE TEST MEDIUM
K881524 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
COOKED MEAT MEDIUM
K881525 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
CHAPMAN STONE MEDIUM
K881526 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
CASMAN MEDIUM BASE
K881527 · JTY
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
CASEIN PEPTONE, LOW VITAMIN
K881528 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
CARY AND BLAIR TRANSPORT MEDIUM
K881529 · JSM
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
BRILLIANT GREEN AGAR W/SULFADIAZINE
K881530 · JSJ
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
BLOOD AGAR BASE, IMPROVED
K881531 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
BLOOD AGAR BASE W/LOW PH
K881532 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
BLOOD AGAR BASE NO. 2
K881533 · JSG
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGAR
K881534 · JSA
Acumedia Manufacturers, Inc.
Microbiology · 10d
Cleared Apr 18, 1988
ANTIBIOTIC MEDIUM #6
K881535 · JSA
Acumedia Manufacturers, Inc.
Microbiology · 10d