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
4057–4080 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jul 14, 1988
ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL
K882535 · LJC
Abbott Laboratories
Microbiology · 23d
Cleared Jul 12, 1988
SCEPTOR ENTERIC MIC PANEL (REVISED 4/88)
K882300 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 40d
Cleared Jul 12, 1988
SCEPTOR ENTERIC MIC/ID PANEL (REVISED 4/88)
K882301 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 40d
Cleared Jul 12, 1988
ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL
K882534 · LIR
Abbott Laboratories
Microbiology · 21d
Cleared Jul 08, 1988
DU PONT VCA-IGM ANTIBODY ELISA KIT
K875204 · LJN
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 203d
Cleared Jul 08, 1988
SCEPTOR- NEW ANTIMICROBIAL AGENT: NORFLOXACIN
K881846 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 67d
Cleared Jul 08, 1988
ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48)
K881894 · GOD
Cambridge Bioscience Corp.
Microbiology · 64d
Cleared Jul 08, 1988
MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE
K882580 · JTW
Precision Dynamics Corp.
Microbiology · 17d
Cleared Jul 06, 1988
LABELING FOR REVISED PASCO MIC AND MIC/ID PANELS
K882029 · JWY
Pasco Laboratories, Inc.
Microbiology · 65d
Cleared Jul 06, 1988
ACCU-CULSHURE TM
K882637 · JTX
Accu-Med Corp.
Microbiology · 9d
Cleared Jul 01, 1988
G-MARK
K880076 · LIC
Bainbridge Laboratories, Inc.
Microbiology · 172d
Cleared Jul 01, 1988
THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007
K882495 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 15d
Cleared Jun 28, 1988
MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181
K882351 · JTZ
Lakewood Biochemical Co., Inc.
Microbiology · 21d
Cleared Jun 22, 1988
ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL
K882277 · GQG
Abbott Laboratories
Microbiology · 22d
Cleared Jun 22, 1988
POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421
K882463 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 7d
Cleared Jun 16, 1988
B. CAT CONFIRM
K880694 · JTO
Scott Laboratories, Inc.
Microbiology · 115d
Cleared Jun 16, 1988
VITEK YEAST BIOCHEMICAL CARD
K881925 · JXB
Vitek Systems, Inc.
Microbiology · 38d
Cleared Jun 08, 1988
SNAP CAMPYLOBACTOR DIAGNOSTIC KIT
K873670 · LQO
Molecular Biosystems, Inc.
Microbiology · 271d
Cleared Jun 07, 1988
BION HSV1-G OR HSV2-G TEST SYSTEM
K881261 · GQO
Bion Ent., Ltd.
Microbiology · 75d
Cleared Jun 07, 1988
INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY
K881617 · LSE
Granbio, Inc.
Microbiology · 53d
Cleared Jun 06, 1988
SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326
K882182 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 13d
Cleared Jun 03, 1988
BION CMV-G TEST SYSTEM
K880679 · GQH
Bion Ent., Ltd.
Microbiology · 105d
Cleared Jun 02, 1988
HYGEIA GC TEST
K881064 · LIR
Hygeia Sciences
Microbiology · 80d
Cleared Jun 02, 1988
DIAMOND'S MEDIUM MODIFIED
K881995 · KZI
Remel Co.
Microbiology · 21d