FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
10897–10920 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 22, 1982
GLUCOSE(ENZYMATIC) REAGENT SET
K821204 · CGA
Omega Medical Electronics
Chemistry · 86d
Cleared Jul 22, 1982
SGPT-UV REAGENT SET
K821206 · CKA
Omega Medical Electronics
Chemistry · 86d
Cleared Jul 22, 1982
UREA NITROGEN REAGENT SET
K821212 · CDW
Omega Medical Electronics
Chemistry · 86d
Cleared Jul 22, 1982
C-REACTIVE PROTEIN CONTROL
K821412 · DCK
Syva Co.
Chemistry · 71d
Cleared Jul 22, 1982
ZETA-CORT
K821931 · CGR
Amf Biological and Diagnostics Co.
Chemistry · 23d
Cleared Jul 22, 1982
TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT
K821944 · JHI
Hybritech, Inc.
Chemistry · 23d
Cleared Jul 22, 1982
125I QUICK-MB TEST KIT FOR QUANTITATION
K821964 · JHT
Intl. Immunoassay Laboratories, Inc.
Chemistry · 21d
Cleared Jul 22, 1982
TITAN GEL CPK/LDH ISOENZYME CONTROL
K821981 · JJT
Helena Laboratories
Chemistry · 16d
Cleared Jul 21, 1982
PREGNOPOST
K821621 · KDT
M.M. Wolfred, Ph.D.
Chemistry · 49d
Cleared Jul 20, 1982
LDH-UV REAGENT SET
K821201 · CFJ
Omega Medical Electronics
Chemistry · 84d
Cleared Jul 20, 1982
TRIGLYCERIDE REAGENT SET
K821205 · CDT
Omega Medical Electronics
Chemistry · 84d
Cleared Jul 20, 1982
SGOT-UV REAGENT SET
K821208 · CIT
Omega Medical Electronics
Chemistry · 84d
Cleared Jul 20, 1982
BIURET (COLORIMETRIC) TOTAL PROTEIN
K821905 · CEK
American Monitor Corp.
Chemistry · 22d
Cleared Jul 20, 1982
BIO-CAL OPERATION CHECK KIT
K821934 · JIS
Bio-Analytics Laboratories, Inc.
Chemistry · 21d
Cleared Jul 20, 1982
ALT ENZYME ASSAY KIT
K821946 · CKA
Travenol Laboratories, S.A.
Chemistry · 20d
Cleared Jul 20, 1982
ORAL THC-CANNABINOIDS DIRECT RIA KIT
K821965 · LAT
Immunalysis Corporation
Chemistry · 18d
Cleared Jul 16, 1982
PREG-PHILE B
K821676 · JHJ
Bio Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Jul 16, 1982
SYVA ADVANCE STANDARDIZATION KIT #2
K821937 · JIS
Syva Co.
Chemistry · 17d
Cleared Jul 16, 1982
SYVA ADVANCE STANDARDIZATION KIT #3
K821938 · JIS
Syva Co.
Chemistry · 17d
Cleared Jul 14, 1982
SGPT REAGENT SET
K821207 · CKD
Omega Medical Electronics
Chemistry · 78d
Cleared Jul 14, 1982
SGOT REAGENT SET
K821209 · CIQ
Omega Medical Electronics
Chemistry · 78d
Cleared Jul 14, 1982
ULTRAZYME PLUS 2GT
K821871 · JPZ
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRACHEM URIC ACID AIDH
K821872 · CDO
Harleco Diagnostics
Chemistry · 19d
Cleared Jul 14, 1982
ULTRACHEM T-BILI
K821873 · CIG
Harleco Diagnostics
Chemistry · 19d