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
3169–3192 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Oct 22, 1993
READAR
K930478 · LRG
Alamar Biosciences, Inc.
Microbiology · 266d
Cleared Oct 12, 1993
SYNERGY SCREEN TEST, MODIFICATION
K921977 · LRG
Baxter Healthcare Corp
Microbiology · 539d
Cleared Oct 12, 1993
MERIDIAN EBV-EA TEST KIT
K925688 · LSE
Fuller Laboratories, Inc.
Microbiology · 334d
Cleared Oct 12, 1993
MERIDIAN EBV-IGG TEST KIT
K925689 · MCD
Fuller Laboratories, Inc.
Microbiology · 334d
Cleared Oct 12, 1993
MERIDIAN EBNA TEST KIT
K925690 · LLM
Fuller Laboratories, Inc.
Microbiology · 334d
Cleared Sep 30, 1993
SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT
K926090 · LJC
Syva Co.
Microbiology · 302d
Cleared Sep 30, 1993
TECHLAB 1-HOUR TOX-A-TEST
K931129 · LLH
Techlab, Inc.
Microbiology · 209d
Cleared Sep 24, 1993
GC II AGAR WITH ISOVITALEX
K932882 · JSO
Becton Dickinson Microbiology Systems
Microbiology · 102d
Cleared Sep 23, 1993
ALAMAR BACTERIAL IDENTIFICATION TEST PANEL
K926002 · JSS
Alamar Biosciences Laboratory, Inc.
Microbiology · 300d
Cleared Sep 21, 1993
G C II AGAR WITH SENSIVITALEX
K932879 · JSO
Becton Dickinson Microbiology Systems
Microbiology · 99d
Cleared Aug 31, 1993
READAR
K925951 · LRG
Alamar Biosciences Laboratory, Inc.
Microbiology · 280d
Cleared Aug 18, 1993
PASCO MIC AND MIC/ID PANELS
K932917 · JWY
Pasco Laboratories, Inc.
Microbiology · 63d
Cleared Aug 10, 1993
UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG
K924689 · LYR
United Biotech, Inc.
Microbiology · 327d
Cleared Aug 10, 1993
STAPH-A-LEX(TM) SYSTEM
K926173 · JWX
Trinity Laboratories, Inc.
Microbiology · 245d
Cleared Aug 10, 1993
REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK
K933118 · JTN
Remel Co.
Microbiology · 46d
Cleared Aug 09, 1993
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA
K923903 · LJY
Biomerieux Vitek, Inc.
Microbiology · 370d
Cleared Jul 20, 1993
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K932082 · JWY
Baxter Diagnostics, Inc.
Microbiology · 81d
Cleared Jul 19, 1993
ADAMS SCIENTIFIC SENSITIVITY DISCS
K932052 · JTN
Adams Scientific, Inc.
Microbiology · 82d
Cleared Jul 16, 1993
ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA
K930002 · LLM
Ortho Diagnostic Systems, Inc.
Microbiology · 193d
Cleared Jul 16, 1993
ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA
K930020 · LJN
Ortho Diagnostic Systems, Inc.
Microbiology · 193d
Cleared Jul 08, 1993
READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS
K925859 · LRG
Alamar Biosciences, Inc.
Microbiology · 233d
Cleared Jun 28, 1993
TURBIQUANT ASL
K915742 · GTQ
Behring Diagnostics, Inc.
Microbiology · 553d
Cleared Jun 25, 1993
BIONOR TRANSPORTMEDIUM
K925450 · JSL
Skoug Research Corp.
Microbiology · 240d
Cleared Jun 25, 1993
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K930469 · JWY
Alamar Biosciences Laboratory, Inc.
Microbiology · 148d