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
3625–3648 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 25, 2000
MODIFICATION TO LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
K001118 · DFC
DiaSorin, Inc.
Chemistry · 18d
Cleared Apr 24, 2000
VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
K001133 · KHS
Ortho-Clinical Diagnostics, Inc.
Chemistry · 14d
Cleared Apr 20, 2000
PICO SMOKERLYZER, MODEL EC-50
K000962 · CCJ
Bedfont Scientific, Ltd.
Chemistry · 27d
Cleared Apr 20, 2000
ASSAYED QCS 1,2, CAT. NOS. 970200, 970500
K000875 · JJY
Bio-Rad
Chemistry · 31d
Cleared Apr 18, 2000
I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER
K001154 · JGS
I-Stat Corp.
Chemistry · 8d
Cleared Apr 18, 2000
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
K000874 · JJW
Bio-Rad
Chemistry · 29d
Cleared Apr 17, 2000
STAT PROFILE PHOX PLUS ANALYZER
K000895 · JGS
Nova Biomedical Corp.
Chemistry · 28d
Cleared Apr 17, 2000
SPIFE CHOLESTEROL PROFILE KIT
K000603 · JHO
Helena Laboratories
Chemistry · 54d
Cleared Apr 17, 2000
DRG AURICA ELISA TESTOSTERONE KIT
K000043 · CDZ
Drg Intl., Inc.
Chemistry · 102d
Cleared Apr 14, 2000
APPRAISE-CARDIO SAMPLE COLLECTION KIT
K993787 · JKA
Osborn Group, Inc.
Chemistry · 157d
Cleared Apr 13, 2000
QUALITROL LIPID CONTROL, LEVELS 1 AND 2
K000810 · JJY
Consolidated Technologies of Wisconsin
Chemistry · 31d
Cleared Apr 11, 2000
SAMPLOK
K000777 · JKA
Itl Corporation Pty, Ltd.
Chemistry · 33d
Cleared Apr 11, 2000
FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
K000471 · CEW
Future Diagnostics B.V.
Chemistry · 57d
Cleared Apr 10, 2000
BAYER ADVIA IMS SYSTEM
K993867 · CIG
Bayer Corp.
Chemistry · 147d
Cleared Apr 05, 2000
RANDOX CALCIUM
K000375 · CIC
Randox Laboratories, Ltd.
Chemistry · 58d
Cleared Apr 03, 2000
WAKO L-TYPE UN TEST
K993925 · CDQ
Wako Chemicals USA, Inc.
Chemistry · 137d
Cleared Mar 31, 2000
RANDOX ALBUMIN
K000483 · CJW
Randox Laboratories, Ltd.
Chemistry · 46d
Cleared Mar 28, 2000
ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
K994278 · CIN
Beckman Coulter, Inc.
Chemistry · 99d
Cleared Mar 27, 2000
SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS
K000600 · KLI
Syva Co., Dade Behring, Inc.
Chemistry · 33d
Cleared Mar 21, 2000
ELECSYS CORTISOL CALCHECK
K000576 · JIX
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Mar 20, 2000
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
K000716 · JHX
Beckman Coulter, Inc.
Chemistry · 17d
Cleared Mar 20, 2000
AVL OPTI R ANALYZER
K000103 · CHL
Avl Scientific Corp.
Chemistry · 67d
Cleared Mar 17, 2000
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K000583 · CGA
Selfcare, Inc.
Chemistry · 24d
Cleared Mar 17, 2000
ELECSYS B-CROSSLAPS CALCHECK
K000042 · JJX
Roche Diagnostics Corp.
Chemistry · 71d