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: Chemistry ×
13,237 results
7057–7080 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 09, 1990
COULTER GLUCOSE REAGENT
K897160 · CFR
Coulter Electronics, Inc.
Chemistry · 71d
Cleared Mar 09, 1990
COULTER ALT (GPT) REAGENT
K897163 · CKA
Coulter Electronics, Inc.
Chemistry · 71d
Cleared Mar 09, 1990
COULTER LD (LDH-L) REAGENT
K897164 · CFJ
Coulter Electronics, Inc.
Chemistry · 71d
Cleared Mar 09, 1990
IMMUNOTECH HDL-CHOLESTEROL TEST
K900036 · LBS
Immunotech Corp.
Chemistry · 66d
Cleared Mar 09, 1990
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
K900120 · LBR
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Mar 09, 1990
NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM
K900775 · JQW
Bio-Rad
Chemistry · 17d
Cleared Mar 06, 1990
PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT
K896482 · LCX
Pacific Biotech, Inc.
Chemistry · 113d
Cleared Mar 06, 1990
IMMUNOTECH CHOLESTEROL TEST
K897036 · CHH
Immunotech Corp.
Chemistry · 78d
Cleared Mar 06, 1990
ALPHA URINE SAMPLE
K900626 · DIF
Toxi-Lab, Inc.
Chemistry · 26d
Cleared Mar 06, 1990
RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT
K900875 · DDG
Reagents Applications, Inc.
Chemistry · 8d
Cleared Mar 01, 1990
CLP CK/LD ISOENZYME/IMMUNO CONTROL
K896465 · JJT
Creative Laboratory Products, Inc.
Chemistry · 108d
Cleared Mar 01, 1990
ENZYMUN TEST(R) TBK
K896991 · CEE
Boehringer Mannheim Corp.
Chemistry · 78d
Cleared Mar 01, 1990
ABBOTT COMMANDER PARALLEL PROCESSING CENTER
K897158 · JQW
Abbott Laboratories
Chemistry · 65d
Cleared Mar 01, 1990
COULTER URIC ACID REAGENT
K897161 · KNK
Coulter Electronics, Inc.
Chemistry · 63d
Cleared Mar 01, 1990
MODIFIED DSL-2300 ACTH RIA
K900147 · CKG
Diagnostic Systems Laboratories, Inc.
Chemistry · 49d
Cleared Mar 01, 1990
STAT FAX(TM)-2100
K900224 · JJQ
Awareness Technology, Inc.
Chemistry · 43d
Cleared Mar 01, 1990
AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781
K900250 · CJE
American Research Products Co.
Chemistry · 43d
Cleared Mar 01, 1990
LYTENING 2Z LYTENING SYSTEM 31
K900300 · CEM
Baxter Healthcare Corp
Chemistry · 38d
Cleared Mar 01, 1990
BICARBONATE REAGENTS PRODUCT #7713 & #7714
K900420 · JFL
American Research Products Co.
Chemistry · 30d
Cleared Mar 01, 1990
FIAGEN(TM) HLH.S
K900621 · CEP
Cyberfluor, Inc.
Chemistry · 21d
Cleared Feb 27, 1990
COBAS READY TOTAL BILIRUBIN REAGENT
K896232 · CIG
Roche Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Feb 27, 1990
COBAS READY ALBUMIN REAGENT
K896235 · CIX
Roche Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Feb 27, 1990
COBAS READY BUN REAGENT
K896236 · JGZ
Roche Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Feb 27, 1990
SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM
K897110 · CEM
Medisense, Inc.
Chemistry · 63d