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
3721–3744 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Nov 18, 1999
ONE-STEP DOUBLE-CHEK PREGNANCY TEST
K992915 · JHI
Biomedical Products Corp.
Chemistry · 80d
Cleared Nov 17, 1999
LIPOPROTEIN (A) SPQ III ANTIBODY REAGENT SET
K993669 · DFC
DiaSorin, Inc.
Chemistry · 16d
Cleared Nov 17, 1999
IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6
K993251 · LIG
Diagnostic Products Corp.
Chemistry · 50d
Cleared Nov 12, 1999
IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06
K993254 · CGN
Diagnostic Products Corp.
Chemistry · 45d
Cleared Nov 12, 1999
MICROALBUSTIX REAGENT STRIPS (OTC)
K991315 · JIR
Bayer Corp.
Chemistry · 207d
Cleared Nov 09, 1999
WAKO L-TYPE UA F TEST
K993469 · KNK
Wako Chemicals USA, Inc.
Chemistry · 27d
Cleared Nov 09, 1999
WAKO L-TYPE TRIGLYCERIDE TEST
K993466 · CDT
Wako Chemicals USA, Inc.
Chemistry · 27d
Cleared Nov 09, 1999
WAKO BILIRUBIN CALIBRATOR
K993219 · JIS
Wako Chemicals USA, Inc.
Chemistry · 43d
Cleared Nov 09, 1999
OSTEOMARK NTX POC
K992997 · JMM
Metrika, Inc.
Chemistry · 63d
Cleared Nov 09, 1999
BAYER ADVIA INTEGRATED MODULAR SYSTEM (IMS)
K992136 · CIT
Bayer Corp.
Chemistry · 138d
Cleared Nov 08, 1999
AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015
K993141 · LCX
Phamatech
Chemistry · 48d
Cleared Nov 04, 1999
BIO-RAD CODA NEONATAL GALT ASSAY
K993536 · KQP
Bio-Rad
Chemistry · 16d
Cleared Nov 01, 1999
K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR
K992976 · DDR
Kamiya Biomedical Co.
Chemistry · 59d
Cleared Nov 01, 1999
QUANTECH CK-MB ASSAY
K984433 · MYT
Quantech , Ltd.
Chemistry · 322d
Cleared Oct 28, 1999
K-ASSAY APO B
K993354 · DER
Kamiya Biomedical Co.
Chemistry · 23d
Cleared Oct 25, 1999
K-ASSAY APO AI
K993345 · DER
Kamiya Biomedical Co.
Chemistry · 20d
Cleared Oct 25, 1999
PICCOLO SODIUM TEST SYSTEM
K993211 · JGS
Abaxis, Inc.
Chemistry · 31d
Cleared Oct 25, 1999
ABBOTT AXSYM HOMOCYSTEINE
K992858 · LPS
Abbott Laboratories
Chemistry · 61d
Cleared Oct 18, 1999
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50
K993178 · CDQ
Diagnostic Chemicals , Ltd.
Chemistry · 25d
Cleared Oct 18, 1999
REP CHOLESTEROL PROFILE KIT
K992971 · JHO
Helena Laboratories
Chemistry · 45d
Cleared Oct 18, 1999
HICHEM TOTAL PROTEIN REAGENT
K992846 · CEK
Elan Holdings, Inc.
Chemistry · 55d
Cleared Oct 18, 1999
HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT,...
K992845 · JIX
Elan Holdings, Inc.
Chemistry · 55d
Cleared Oct 18, 1999
N-GENEOUS LDL-ST CHOLESTEROL REAGENT, N-GENEOUS LDL-ST CHOLESTEROL...
K992766 · MRR
Genzyme Corp.
Chemistry · 62d
Cleared Oct 18, 1999
INSURE PRO TEST
K992695 · JHI
Inbios Intl., Inc.
Chemistry · 68d