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
7081–7104 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 27, 1990
DIRECT BILIRUBIN REAGENT
K900259 · CIG
Medical Analysis Systems, Inc.
Chemistry · 41d
Cleared Feb 27, 1990
AUTOREADER CALIBRATION TEST PLATE
K900579 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 20d
Cleared Feb 26, 1990
POSITIVE AND NEGATIVE HCG SERUM CONTROLS
K896875 · JJX
Armkel, LLC
Chemistry · 80d
Cleared Feb 26, 1990
SATELLITE G BLOOD GLUCOSE MONITORING SYSTEM
K896951 · CGA
Medisense, Inc.
Chemistry · 73d
Cleared Feb 26, 1990
LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT
K897150 · CHI
Toyo Jozo Co., Ltd.
Chemistry · 62d
Cleared Feb 26, 1990
REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175
K900251 · CEF
Helena Laboratories
Chemistry · 40d
Cleared Feb 23, 1990
CARBON DIOXIDE REAGENT
K896812 · KHS
Pointe Scientific, Inc.,
Chemistry · 81d
Cleared Feb 23, 1990
TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD)
K896829 · JGT
Technicon Instruments Corp.
Chemistry · 81d
Cleared Feb 23, 1990
THYROID STIMULATING HORMONE-EIA-XT
K896867 · JLW
In Vitro Diagnostics, Inc.
Chemistry · 79d
Cleared Feb 23, 1990
ABBOTT SPECTRUM URIC ACID REAGENT KIT
K896954 · KNK
Abbott Laboratories
Chemistry · 71d
Cleared Feb 23, 1990
COULTER AST (GOT) REAGENT
K897165 · CIT
Coulter Electronics, Inc.
Chemistry · 57d
Cleared Feb 23, 1990
COULTER TOTAL PROTEIN REAGENT
K897166 · CEK
Coulter Electronics, Inc.
Chemistry · 57d
Cleared Feb 23, 1990
QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT
K897169 · CDT
Photec Diagnostics, Inc.
Chemistry · 57d
Cleared Feb 16, 1990
CHOLESTEROL TEST KIT
K895951 · CHH
Elite Technology, Inc.
Chemistry · 128d
Cleared Feb 16, 1990
REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083
K896170 · JHT
Helena Laboratories
Chemistry · 114d
Cleared Feb 16, 1990
COBAS READY URIC ACID REAGENT
K896227 · KNK
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY CARDIO PROFILE REAGENT STRIP
K896228 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY PROFILE 1 REAGENT STRIP
K896229 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY TOTAL PROTEIN REAGENT
K896230 · CEK
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY TRIGLYCERIDE REAGENT
K896231 · CDT
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY LIVER PROFILE REAGENT STRIP
K896233 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY STAT PROFILE REAGENT STRIP
K896234 · CKA
Roche Diagnostic Systems, Inc.
Chemistry · 108d
Cleared Feb 16, 1990
COBAS READY ALT REAGENT
K896237 · CKD
Roche Diagnostic Systems, Inc.
Chemistry · 108d
Cleared Feb 16, 1990
COBAS READY AST REAGENT
K896238 · CIS
Roche Diagnostic Systems, Inc.
Chemistry · 109d