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
5833–5856 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 22, 1993
GLUCOSE-HK TEST
K931890 · CFR
Em Diagnostic Systems, Inc.
Chemistry · 98d
Cleared Jul 20, 1993
IQ TT4 ASSAY
K931295 · CDX
Becton Dickinson Advanced Diagnostics
Chemistry · 127d
Cleared Jul 19, 1993
LIQUID AMYLASE REAGENT SET
K930475 · JFJ
Pointe Scientific, Inc.,
Chemistry · 172d
Cleared Jul 09, 1993
MODEL 3D3 OSMOMETER
K925970 · JJM
Advanced Instruments, Inc.
Chemistry · 226d
Cleared Jul 09, 1993
SYSTEMATE CREATININE TEST ITEM NUMBER 65413
K932160 · CGX
Em Diagnostic Systems, Inc.
Chemistry · 66d
Cleared Jul 08, 1993
OPUS(R) TOTAL B-HCG TEST SYSTEM
K932279 · JHI
Pb Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Jul 06, 1993
ROCHE CARDIOTROL-CK
K930889 · JJT
Roche Diagnostic Systems, Inc.
Chemistry · 134d
Cleared Jun 29, 1993
DIRECT BILIRUBIN
K930679 · CIG
Horizon Diagnostics, Inc.
Chemistry · 140d
Cleared Jun 29, 1993
QUICKVUE ONE-STEP HCG COMBO
K932042 · JHI
Quidel Corp.
Chemistry · 63d
Cleared Jun 29, 1993
LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II
K932076 · JJY
Bio-Rad
Chemistry · 61d
Cleared Jun 29, 1993
SAS(TM) SERUM/URINE HCG
K932409 · DHA
Sa Scientific, Inc.
Chemistry · 42d
Cleared Jun 29, 1993
DOCUMENT ENZYME
K932458 · JJY
Casco Standards
Chemistry · 39d
Cleared Jun 25, 1993
REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM
K922646 · JIS
Behring Diagnostics, Inc.
Chemistry · 387d
Cleared Jun 25, 1993
GLUCOMETER M+ BLOOD GLUCOSE METER
K931310 · CGA
Heraeus Kulzer, Inc.
Chemistry · 102d
Cleared Jun 25, 1993
QUANTIMETRIX C-CLEAR(TM)
K931523 · JMA
Quantimetrix Corp.
Chemistry · 91d
Cleared Jun 24, 1993
GLUCOMETER ENCORE QA BLOOD GLUCOSE METER
K926361 · CFR
Heraeus Kulzer, Inc.
Chemistry · 185d
Cleared Jun 22, 1993
CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION
K924755 · EXI
Convatec, A Division of E.R. Squibb &...
Chemistry · 272d
Cleared Jun 22, 1993
QUICKVUE(TM) ONE-STEP HCG CONTROLS (POSIT/NEGATI)
K931761 · JJX
Quidel Corp.
Chemistry · 75d
Cleared Jun 16, 1993
ABBOTT IMX2 ANALYER
K931970 · JJI
Abbott Laboratories
Chemistry · 55d
Cleared Jun 15, 1993
TES-TAPE
K922207 · CGA
Lilly Research Laboratories
Chemistry · 399d
Cleared Jun 15, 1993
PRO-STEP PT HCG
K925303 · JHI
Disease Detection International, Inc.
Chemistry · 237d
Cleared Jun 15, 1993
ACCESS(R) THYROXINE ASSAY
K926475 · KLI
Bio-Rad Laboratories, Inc.
Chemistry · 168d
Cleared Jun 15, 1993
COAT-A-COUNT INTACT PTH IRMA
K930008 · CEW
Diagnostic Products Corp.
Chemistry · 162d
Cleared Jun 15, 1993
IMX(R) STAT CK-MB
K931172 · JHY
Abbott Laboratories
Chemistry · 99d