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
6961–6984 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 24, 1990
QUICK CHEM II
K901695 · JJQ
Seradyn, Inc.
Chemistry · 44d
Cleared May 23, 1990
URIC ACID TEST KIT
K901001 · KNK
Elite Technology, Inc.
Chemistry · 82d
Cleared May 23, 1990
COULTER CK (CREATINE KINASE) REAGENT
K901267 · CGS
Coulter Corp.
Chemistry · 68d
Cleared May 23, 1990
ROCHE REAGENT FOR MAGNESIUM
K901758 · JGJ
Roche Diagnostic Systems, Inc.
Chemistry · 35d
Cleared May 17, 1990
MICROPLATE REAGENT DISPENSER
K900599 · JQW
Denley Instruments, Inc.
Chemistry · 98d
Cleared May 17, 1990
EZ-BEAD PHENYTOIN ENZYME IMMUNOASSAY KIT
K901080 · DIP
Immunotech Corp.
Chemistry · 71d
Cleared May 17, 1990
IRON/TOTAL IRON BINDING CAPACITY
K901561 · JIY
Tech-Co, Inc.
Chemistry · 44d
Cleared May 15, 1990
ENZYMUN TEST(R) FT4 (FREE THYROXINE)
K900883 · CEC
Boehringer Mannheim Corp.
Chemistry · 78d
Cleared May 15, 1990
ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER
K900887 · CGZ
Abbott Laboratories
Chemistry · 78d
Cleared May 15, 1990
DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI
K901017 · JFJ
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 71d
Cleared May 15, 1990
MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB
K901450 · JHT
Intl. Immunoassay Laboratories, Inc.
Chemistry · 48d
Cleared May 14, 1990
CHEM I CLINICAL ANALYZER URINE MAGNESIUM
K901124 · JGJ
Technicon Instruments Corp.
Chemistry · 63d
Cleared May 14, 1990
WAKO(TM) AUTOKIT URIC ACID
K901544 · KNK
Wako Chemicals USA, Inc.
Chemistry · 41d
Cleared May 10, 1990
OLYMPUS(TM) TOTAL BILIRUBIN
K897174 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 134d
Cleared May 10, 1990
CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN
K901123 · CDQ
Technicon Instruments Corp.
Chemistry · 59d
Cleared May 10, 1990
MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050
K901345 · CGJ
Medix Biotech, Inc.
Chemistry · 49d
Cleared May 10, 1990
MPR-4A - MICRO-PLATE READER
K901965 · JJQ
Tosoh Corp.
Chemistry · 10d
Cleared May 04, 1990
MICROTEK MEDICAL'S BLOOD COLLECTION KIT
K900726 · JKA
Microbio-Medics, Inc.
Chemistry · 78d
Cleared May 04, 1990
BIOSIGN HCG-ONE STEP PREGNANCY TEST
K901011 · JHI
Princeton Biomedix
Chemistry · 60d
Cleared May 04, 1990
CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE)
K901229 · CGX
Technicon Instruments Corp.
Chemistry · 51d
Cleared May 02, 1990
ENZYMUN TEST(R) CORTISOL
K900485 · CGR
Boehringer Mannheim Corp.
Chemistry · 90d
Cleared May 02, 1990
COLORIMETRIC CHLORIDE PRODUCT #4314125
K900827 · CHI
American Research Products Co.
Chemistry · 70d
Cleared May 02, 1990
AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM
K901674 · KHO
Tosoh Corp.
Chemistry · 22d
Cleared May 02, 1990
COBAS-FP REAGENTS FOR VANCOMYCIN
K901759 · LEH
Roche Diagnostic Systems, Inc.
Chemistry · 14d