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
2449–2472 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Sep 25, 1997
FRESH CELLS NCI H292
K973210 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 29d
Cleared Sep 25, 1997
FRESH CELLS MV1LU
K973211 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 29d
Cleared Sep 25, 1997
FRESH CELLS WI-38
K973212 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 29d
Cleared Sep 25, 1997
FRESH CELLS LLC-MK2
K973213 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 29d
Cleared Sep 25, 1997
FRESH CELLS HFF
K973214 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 29d
Cleared Sep 17, 1997
RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE
K971508 · KIR
Bio-Whittaker, Inc., A Cambrex Co.
Microbiology · 145d
Cleared Sep 10, 1997
VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES
K971494 · GNX
Zymetx, Inc.
Microbiology · 139d
Cleared Sep 08, 1997
STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
K972030 · JWX
Oxoid , Ltd.
Microbiology · 98d
Cleared Sep 08, 1997
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K972524 · JWY
Dade Intl., Inc.
Microbiology · 63d
Cleared Sep 08, 1997
MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN
K972688 · JWY
Dade Microscan, Inc.
Microbiology · 63d
Cleared Aug 29, 1997
FRESHCELLS
K972414 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 63d
Cleared Aug 28, 1997
REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN
K972359 · JSO
Remel, L.P.
Microbiology · 64d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP B
K972386 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP A
K972387 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP C
K972388 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H D
K972389 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H C
K972390 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H B
K972391 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA H A
K972392 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN BRUCELLA ABORTUS
K972394 · GSO
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN SALMONELLA O GROUP D
K972395 · GNC
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 25, 1997
VISTA ANTIGEN BRUCELLA MELITENSIS
K972396 · GSO
Lee Laboratories, Inc.
Microbiology · 60d
Cleared Aug 22, 1997
ACCURUN 146 CMV IGM POSITIVE CONTROL
K972884 · LKQ
Boston Biomedica, Inc.
Microbiology · 17d
Cleared Aug 20, 1997
MYCOPLASMA IGM ELISA TEST SYSTEM
K971503 · LJZ
Zeus Scientific, Inc.
Microbiology · 118d