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
3817–3840 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 25, 1999
N/T PROTEIN CONTROL LC
K991704 · JJY
Dade Behring, Inc.
Chemistry · 37d
Cleared Jun 24, 1999
MTM BIOSCANNER C TEST STRIPS
K990688 · CHH
Polymer Technology Systems, Inc.
Chemistry · 119d
Cleared Jun 22, 1999
TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001
K991146 · JLW
Biocheck, Inc.
Chemistry · 78d
Cleared Jun 22, 1999
BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT
K990993 · JLW
Biocheck, Inc.
Chemistry · 90d
Cleared Jun 22, 1999
DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL
K983344 · CGA
Dade Behring, Inc.
Chemistry · 272d
Cleared Jun 21, 1999
QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KIT
K990654 · JIA
Quantase , Ltd.
Chemistry · 112d
Cleared Jun 21, 1999
QUANTASE TOTAL GALACTOSE SCREENING ASSAY
K990644 · JIA
Quantase , Ltd.
Chemistry · 115d
Cleared Jun 18, 1999
CHIRON DIAGNOSTICS ACS: 180 FT3
K991692 · CDP
Chiron Diagnostics Corp.
Chemistry · 31d
Cleared Jun 18, 1999
DIRECT HDL-CHOLESTEROL REAGENT
K990581 · LBS
Kamiya Biomedical Co.
Chemistry · 115d
Cleared Jun 18, 1999
HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT...
K990250 · LBT
Morax
Chemistry · 143d
Cleared Jun 16, 1999
ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
K991498 · JIA
Neometrics, Inc.
Chemistry · 48d
Cleared Jun 11, 1999
CARDIOQUANT CARDIAC ASSESSMENT CONTROLS
K991447 · JJY
Spectral Diagnostics, Inc.
Chemistry · 46d
Cleared Jun 10, 1999
K-ASSAY MICROALBUMIN CALIBRATOR SET
K991166 · JIX
Kamiya Biomedical Co.
Chemistry · 64d
Cleared Jun 09, 1999
IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
K991797 · JHX
Diagnostic Products Corp.
Chemistry · 14d
Cleared Jun 09, 1999
IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
K991796 · DDR
Diagnostic Products Corp.
Chemistry · 14d
Cleared Jun 09, 1999
IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5
K991795 · MMI
Diagnostic Products Corp.
Chemistry · 14d
Cleared Jun 02, 1999
BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
K991432 · KLI
Biocheck, Inc.
Chemistry · 37d
Cleared Jun 02, 1999
TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
K991311 · CDP
Biocheck, Inc.
Chemistry · 47d
Cleared Jun 02, 1999
THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY
K990658 · JLW
Little Nell Labs, Inc.
Chemistry · 93d
Cleared Jun 01, 1999
MODIFICATION OF N PROTEIN STANDARD SL
K991181 · JIX
Dade Behring, Inc.
Chemistry · 55d
Cleared May 28, 1999
INSURE PREGNANCY TEST
K991515 · DHA
Inbios Intl., Inc.
Chemistry · 28d
Cleared May 28, 1999
MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN...
K991299 · JHT
Princeton BioMeditech Corp.
Chemistry · 52d
Cleared May 28, 1999
MODIFICATION TO ALCYON DIRECT BILIRUBIN
K991175 · CIG
Abbott Laboratories
Chemistry · 60d
Cleared May 28, 1999
GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM
K991156 · JOC
Great Smokies Diagnostic Laboratory
Chemistry · 51d