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
5977–6000 of 7,067
Search insights Median review: 63d Cleared: 99% Top manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic Lead specialty: Microbiology
Cleared Dec 03, 1982
AGAR P
K823102 · JSJ
Dms Laboratories
Microbiology · 44d
Cleared Dec 03, 1982
SMITH'S MEDIUM
K823139 · JSJ
Granite Diagnostics, Inc.
Microbiology · 39d
Cleared Dec 03, 1982
SCHAEDLER AGARS
K823248 · JSJ
Granite Diagnostics, Inc.
Microbiology · 32d
Cleared Dec 03, 1982
MYCAREL AGAR MYCOBROTIC AGAR
K823308 · JSJ
Troy Biologicals, Inc.
Microbiology · 28d
Cleared Dec 03, 1982
MARTIN & LEMIS AGAR W/VCAT INHIBITOR
K823309 · JTY
Troy Biologicals, Inc.
Microbiology · 28d
Cleared Dec 03, 1982
HERPES TRANSETTE
K823443 · JTW
Spectrum Diagnostic, Inc.
Microbiology · 17d
Cleared Nov 29, 1982
FLUOROSET IMMUNOFLUORESCENT ANTIBODY
K822785 · GQL
Immulok, Inc.
Microbiology · 76d
Cleared Nov 22, 1982
AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC
K822809 · JTN
General Diagnostics
Microbiology · 63d
Cleared Nov 22, 1982
NYSTYMOGRAPH ACCESS
K823111 · GNN
Kelleher Corp.
Microbiology · 28d
Cleared Nov 17, 1982
ANTISERUM TO HUMAN KAPPA
K822666 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
ANTISERUM TO HUMAN LAMBDA
K822667 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
ANTISERUM TO HUMAN IGA
K822668 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
ANTISERUM TO HUMAN IGG
K822669 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
ANTISERUM TO HUMAN IGM
K822670 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
ANTISERUM TO HUMAN GOBULIN
K822671 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
FITC ANTISERA TO HUMAN KAPPA
K822673 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
FITC ANTISERA TO HUMAN LAMBDA
K822674 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
FITC ANTISERA TO HUMAN IGA
K822675 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
FITC ANTISERA TO HUMAN IGG
K822676 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
FITC ANTISERA TO HUMAN IGM
K822677 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
FITC ANTISERA TO HUMAN GOBULIN
K822678 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
FITC ANTISERA TO HUMAN C3
K822679 · DFH
Amico Lab, Inc.
Microbiology · 75d
Cleared Nov 17, 1982
STREP SELECTIVE AGAR
K822997 · JSI
Granite Diagnostics, Inc.
Microbiology · 36d
Cleared Nov 17, 1982
RITC-ANTI HUMAN IGA, IGG, KAPPA, LAMBDA
K823121 · DFH
Amico Lab, Inc.
Microbiology · 23d