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
2665–2688 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Jun 18, 1996
SAS SALMONELLA O FACTOR 20 ANTISERUM
K961948 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O FACTOR 14 ANTISERUM
K961949 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM
K961950 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O FACTOR 6 ANTISERUM
K961951 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS
K961952 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELA H Z24 ANTISERUM
K961953 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H Z35 ANTISERUM
K961954 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H Z42 ANTISERUM
K961955 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H G,M,Q ANTISERMU
K961956 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H Z4, Z32 ANTISERUM
K961957 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H Z4 COMPLEX ANTISERUM
K961958 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H Z4, Z24 ANTISERUM
K961960 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA H F,G,T ANTISERUM
K961961 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM
K961962 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM
K961963 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM
K961964 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM
K961966 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 18, 1996
SAS SALMONELLA O POLY B ANTISERUM
K961967 · GRM
Sa Scientific, Inc.
Microbiology · 29d
Cleared Jun 17, 1996
IMMULITE CMV IGG
K950672 · LFZ
Diagnostic Products Corp.
Microbiology · 490d
Cleared Jun 17, 1996
VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES
K950838 · GNT
Zymetx, Inc.
Microbiology · 479d
Cleared Jun 17, 1996
SERAQUEST TOXOPLASMA IGG
K960092 · LGD
Quest Intl., Inc.
Microbiology · 158d
Cleared Jun 17, 1996
SYPHILIS IGG HUMAN SERUM CONTROLS
K960493 · LIP
Pyramid Biological Corp.
Microbiology · 137d
Cleared Jun 17, 1996
COLISCREEN
K961191 · JTO
Hardy Diagnostics
Microbiology · 83d
Cleared Jun 07, 1996
MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM
K951709 · LSR
Mardx Diagnostics, Inc.
Microbiology · 421d