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
3769–3792 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 13, 1999
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P,...
K992803 · CHH
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Sep 13, 1999
K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP MULTI-CALIBRATORC
K992311 · DCK
Kamiya Biomedical Co.
Chemistry · 66d
Cleared Sep 09, 1999
CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
K991834 · CKD
Cholestech Corp.
Chemistry · 104d
Cleared Sep 08, 1999
GO GLUCOSE MONITORING SYSTEM
K991754 · CGA
Lxn Corp.
Chemistry · 107d
Cleared Sep 03, 1999
URINE CHEMISTRY CONTROL, LEVEL 2
K992578 · JJW
Consolidated Technologies, Inc.
Chemistry · 32d
Cleared Sep 03, 1999
URINE CHEMISTRY CONTROL, LEVEL 1
K992576 · JJW
Consolidated Technologies, Inc.
Chemistry · 32d
Cleared Sep 02, 1999
LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580
K992172 · JJY
Bio-Rad
Chemistry · 66d
Cleared Sep 02, 1999
ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02
K991762 · CJE
A.P. Total Care, Inc.
Chemistry · 101d
Cleared Sep 02, 1999
MAGNESIUM PRODUCT NO'S, 112-01, 112-02
K991761 · JGJ
A.P. Total Care, Inc.
Chemistry · 101d
Cleared Sep 01, 1999
DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE
K990873 · JMT
Ameritek, Inc.
Chemistry · 169d
Cleared Aug 26, 1999
ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
K992397 · JHI
Cenogenics Corp.
Chemistry · 38d
Cleared Aug 26, 1999
PICCOLO METLYTE 7 REAGENT DISC
K992140 · JLB
Abaxis, Inc.
Chemistry · 63d
Cleared Aug 24, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I RANGE VERIFIERS
K992349 · JJY
Ortho-Clinical Diagnostics, Inc.
Chemistry · 41d
Cleared Aug 20, 1999
CHOLESITE TEST SYSTEM
K992132 · CHH
Gds Technology, LLC
Chemistry · 58d
Cleared Aug 20, 1999
RLP CHOLESTEROL IMMUNOSEPARATION ASSAY
K991083 · CHH
Otsuka Pharmaceutical Co., Ltd.
Chemistry · 142d
Cleared Aug 19, 1999
LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
K991664 · LBS
A.P. Total Care, Inc.
Chemistry · 97d
Cleared Aug 12, 1999
ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
K992029 · LBR
Elan Diagnostics
Chemistry · 57d
Cleared Aug 11, 1999
LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3
K992550 · JJY
Bio-Rad
Chemistry · 12d
Cleared Aug 10, 1999
AIA-PACK FOLATE ASSAY
K992365 · CGN
Tosoh Medics, Inc.
Chemistry · 26d
Cleared Aug 10, 1999
CARESIDE MG
K991717 · JGJ
Careside, Inc.
Chemistry · 82d
Cleared Aug 10, 1999
HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
K991665 · LBS
A.P. Total Care, Inc.
Chemistry · 88d
Cleared Aug 10, 1999
DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE
K984530 · JFY
Metrika, Inc.
Chemistry · 232d
Cleared Aug 05, 1999
AUTOHDL CHOLESTEROL REAGENT SET
K992002 · LBR
Pointe Scientific, Inc.,
Chemistry · 51d
Cleared Aug 03, 1999
CARESIDE AMMONIA
K991371 · JID
Careside, Inc.
Chemistry · 105d