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
2689–2712 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 07, 1996
CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY
K951821 · LIN
Light Diagnostics
Microbiology · 414d
Cleared Jun 07, 1996
LMD CRYPTOSPORIDIUM ANTIGEN DETECTION
K955345 · MHJ
Lmd Laboratories
Microbiology · 199d
Cleared Jun 07, 1996
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT...
K960183 · LYR
Smithkline Diagnostics, Inc.
Microbiology · 143d
Cleared Jun 05, 1996
MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM
K950829 · LSR
Mardx Diagnostics, Inc.
Microbiology · 468d
Cleared May 31, 1996
SAS SHIGELLA SONNEI FORM II ANTISERUM
K961537 · GNB
Sa Scientific, Inc.
Microbiology · 39d
Cleared May 30, 1996
IMX SELECT CHLAMYDIA
K936054 · LJC
Abbott Laboratories
Microbiology · 891d
Cleared May 30, 1996
DIRECTIGEN MENINGITIS COMBO TEST
K952791 · GTJ
Bd Becton Dickinson Vacutainer...
Microbiology · 346d
Cleared May 30, 1996
H292 CELL CULTURE
K960909 · KIR
Neogenex
Microbiology · 86d
Cleared May 30, 1996
MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL
K961042 · LRH
Dade Microscan, Inc.
Microbiology · 77d
Cleared May 23, 1996
VISUWELL REAGIN II
K952802 · GMQ
Biomira Diagnostics, Inc.
Microbiology · 339d
Cleared May 23, 1996
PREMIER HSV PLUS
K953839 · LGC
Meridian Diagnostics, Inc.
Microbiology · 281d
Cleared May 21, 1996
BACTEC(R) 9000TB SYSTEM
K946268 · MDB
Becton Dickinson Diagnostic...
Microbiology · 515d
Cleared May 21, 1996
HELISAL RAPID BLOOD TEST
K953686 · LYR
Cortecs, Ltd.
Microbiology · 295d
Cleared May 20, 1996
ETEST SUBMISSION FOR IMIPENEM
K960989 · JWY
Ab Biodisk
Microbiology · 70d
Cleared May 20, 1996
ETEST SUBMISSION FOR VANCOMYCIN
K960990 · JWY
Ab Biodisk
Microbiology · 70d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML)
K961528 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 12 ANTISERUM
K961529 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA BOYDII TYPE 13 ANTISERUM
K961531 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM
K961532 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM
K961533 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML)
K961534 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM
K961535 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM
K961538 · GNB
Sa Scientific, Inc.
Microbiology · 28d
Cleared May 20, 1996
SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM
K961539 · GNB
Sa Scientific, Inc.
Microbiology · 28d