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
7969–7992 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 16, 1988
VISION(R) THYROXINE (T4)
K880662 · KLI
Abbott Laboratories
Chemistry · 28d
Cleared Mar 15, 1988
ION TRAP DETECTOR
K880090 · DOP
Finnigan Corp.
Chemistry · 63d
Cleared Mar 15, 1988
GLUCOSE HEXOKINASE
K880236 · CFR
Tech-Neal Scientific, Inc.
Chemistry · 55d
Cleared Mar 15, 1988
TRIGLYCERIDE
K880238 · CDT
Tech-Neal Scientific, Inc.
Chemistry · 55d
Cleared Mar 15, 1988
KONE CALCIUM TEST
K880242 · CJY
The Rupp & Bowman Co.
Chemistry · 55d
Cleared Mar 15, 1988
CO2 REAGENT
K880268 · KHS
Sigma Diagnostics, Inc.
Chemistry · 54d
Cleared Mar 15, 1988
ALKALINE PHOSPHATASE REAGENT SET
K880307 · CJE
Tech-Neal Scientific, Inc.
Chemistry · 50d
Cleared Mar 15, 1988
HCG-NOSTICK
K880328 · JHJ
Organon Teknika Corp.
Chemistry · 49d
Cleared Mar 15, 1988
TOTAL BILIRUBIN PROCEDURE RUN ON A DEMAND INSTRU.
K880395 · CIG
Data Medical Associates, Inc.
Chemistry · 46d
Cleared Mar 15, 1988
TOTAL BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.
K880396 · CIG
Data Medical Associates, Inc.
Chemistry · 46d
Cleared Mar 15, 1988
DIRECT BILIRUBIN PROCEDURE RUN ON A AU5000 INSTRU.
K880397 · CIG
Data Medical Associates, Inc.
Chemistry · 46d
Cleared Mar 15, 1988
LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)
K880495 · JJW
Bio-Rad
Chemistry · 40d
Cleared Mar 15, 1988
CONCEP-7-BHCG
K880577 · JHI
Leeco Diagnostics, Inc.
Chemistry · 34d
Cleared Mar 15, 1988
TRIGLYCERIDES (GPO-TRINDER)
K880628 · CDT
Tech-Co, Inc.
Chemistry · 28d
Cleared Mar 15, 1988
EASY-TEST LACTIC ACID (LA)
K880787 · KHP
Diagnostic Systems
Chemistry · 18d
Cleared Mar 03, 1988
GLUCOSE (HEXOKINASE)
K874846 · CFR
Tech-Co, Inc.
Chemistry · 100d
Cleared Mar 03, 1988
TECHNICON CHEM 1(TM) SYSTEM
K874916 · LDR
Technicon Instruments Corp.
Chemistry · 91d
Cleared Mar 03, 1988
CIBA CORNING MODEL 644
K875098 · JXR
Ciba Corning Diagnostics Corp.
Chemistry · 84d
Cleared Mar 03, 1988
AST (SGOT) REAGENT SET
K880276 · CIT
Tech-Neal Scientific, Inc.
Chemistry · 42d
Cleared Mar 03, 1988
T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE
K880388 · CDP
Serono Diagnostics, Inc.
Chemistry · 35d
Cleared Mar 03, 1988
LYPHOCHEK SPINAL FLUID CONTROL (HUMAN)
K880494 · JJY
Bio-Rad
Chemistry · 28d
Cleared Mar 01, 1988
(SKD) CHOLESTEROL TEST KIT
K875131 · CHH
Smithkline Diagnostics, Inc.
Chemistry · 77d
Cleared Mar 01, 1988
DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL
K880175 · JJY
Baxter Healthcare Corp
Chemistry · 46d
Cleared Mar 01, 1988
BINAX PROLACTIN IRMA DIAGNOSTIC KIT
K880218 · CFT
Binax, Inc.
Chemistry · 41d