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
1393–1416 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 23, 2011
EME SELF MONITORING BLOOD GLUCOSE SYSTEM, EME PRO SELF MONITORING BLOOD...
K112901 · LFR
Eps Bio Technology Corp.
Chemistry · 81d
Cleared Dec 23, 2011
AU5800(R) CHEMISTRY ANALYZER
K112412 · CEM
Beckman Coulter, Inc.
Chemistry · 123d
Cleared Dec 23, 2011
GLUCOSE METER-CHECK CONTROL FOR NIPRO TRUERESULT
K112352 · JJX
Bionostics, Inc.
Chemistry · 129d
Cleared Dec 23, 2011
ROCHE ACETAMINOPHEN ASSAY
K110726 · LDP
Roche Diagnostics
Chemistry · 282d
Cleared Dec 23, 2011
TINA-QUANT HBA1C GEN.2
K110313 · LCP
Roche Diagnostics
Chemistry · 324d
Cleared Dec 20, 2011
I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
K112430 · KHP
Abbott Pont of Care, Inc.
Chemistry · 118d
Cleared Dec 20, 2011
FORA D40 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
K101926 · NBW
Taidoc Technology Corporation
Chemistry · 529d
Cleared Dec 19, 2011
ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
K112443 · CDD
Axis-Shield Diagnostics, Ltd.
Chemistry · 117d
Cleared Dec 15, 2011
FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM
K112275 · NBW
Taidoc Technology Corporation
Chemistry · 129d
Cleared Dec 14, 2011
HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL,...
K111753 · CHH
Hitachi Chemical Diagnostics, Inc.
Chemistry · 175d
Cleared Dec 09, 2011
PRESAGE ST2 ASSAY
K111452 · OYG
Critical Care Diagnostics, Inc. (Dba...
Chemistry · 198d
Cleared Dec 07, 2011
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER...
K103544 · NBW
Agamatrix, Inc.
Chemistry · 370d
Cleared Dec 06, 2011
PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL
K111363 · JXN
Medica Corp.
Chemistry · 204d
Cleared Dec 02, 2011
MAGNESIUM ASSAY
K111915 · JGJ
Sekisui Diagnostics P.E.I., Inc.
Chemistry · 149d
Cleared Dec 02, 2011
ESENSOR WARFARIN SENSITIVITY SALIVA TEST
K110786 · NSU
GenMark Diagnostics, Inc.
Chemistry · 255d
Cleared Dec 02, 2011
ORAGENE-DX OGD-500
K110701 · OYJ
DNA Genotek, Inc.
Chemistry · 263d
Cleared Dec 01, 2011
RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI...
K112337 · JJY
Randox Laboratories, Ltd.
Chemistry · 108d
Cleared Dec 01, 2011
ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
K111335 · CKG
Tosoh Bioscience, Inc.
Chemistry · 203d
Cleared Dec 01, 2011
PRESTIGE 24I
K103531 · CFR
Tokyo Boeki Medisys, Inc.
Chemistry · 365d
Cleared Nov 23, 2011
ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS,...
K110619 · MRG
Biokit, S.A.
Chemistry · 265d
Cleared Nov 23, 2011
ROM PLUS
K110605 · NQM
Clinical Innovations, LLC
Chemistry · 266d
Cleared Nov 22, 2011
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS
K113139 · DIO
Lin-Zhi International, Inc.
Chemistry · 29d
Cleared Nov 22, 2011
DIMENSION CLINICAL CHEMISTRY SYSTEM
K112999 · JJE
Siemens Healthcare Diagnostics
Chemistry · 46d
Cleared Nov 22, 2011
TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE...
K112963 · NBW
Taidoc Technology Corporation
Chemistry · 48d