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
2641–2664 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 03, 2004
OLYMPUS LACTATE, OSR6193
K042406 · JIT
Olympus America, Inc.
Chemistry · 91d
Cleared Dec 01, 2004
GAMMA-B 1,25-DIHYDROXY VITAMIN D
K042519 · MRG
Immunodiagnostic Systems , Ltd.
Chemistry · 76d
Cleared Dec 01, 2004
VITROS CHEMISTRY PRODUCTS VALP REAGENT
K042476 · LEG
Ortho-Clinical Diagnostics, Inc.
Chemistry · 79d
Cleared Nov 24, 2004
ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE
K043175 · NHG
Roche Diagnostics Corp.
Chemistry · 8d
Cleared Nov 24, 2004
LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
K042865 · DIF
Bio-Rad
Chemistry · 37d
Cleared Nov 24, 2004
SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL
K042443 · CHH
Arkray, Inc.
Chemistry · 76d
Cleared Nov 24, 2004
IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE)
K041747 · DJG
Lifepoint,Inc
Chemistry · 148d
Cleared Nov 24, 2004
THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS
K041427 · CGA
Arkray, Inc.
Chemistry · 180d
Cleared Nov 23, 2004
HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B
K041928 · LBS
Diagnostic Chemicals , Ltd.
Chemistry · 127d
Cleared Nov 23, 2004
LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40
K041927 · MRR
Diagnostic Chemicals , Ltd.
Chemistry · 127d
Cleared Nov 23, 2004
HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278
K041926 · JIX
Diagnostic Chemicals , Ltd.
Chemistry · 127d
Cleared Nov 19, 2004
VITROS CHEMISTRY PRODUCTS TRFRN REAHENT
K042477 · DDG
Ortho-Clinical Diagnostics, Inc.
Chemistry · 67d
Cleared Nov 19, 2004
MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD
K042347 · NBC
Dade Behring, Inc.
Chemistry · 81d
Cleared Nov 19, 2004
INSTANT-VIEW TROPONIN I TEST
K042227 · MMI
Alfa Scientific Designs, Inc.
Chemistry · 94d
Cleared Nov 18, 2004
VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE...
K042643 · DCF
Ortho-Clinical Diagnostics, Inc.
Chemistry · 52d
Cleared Nov 18, 2004
QUIKREAD CRP CALIBRATOR SET
K042625 · JJY
Orion Diagnostica, OY
Chemistry · 52d
Cleared Nov 18, 2004
VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22...
K042521 · JIT
Ortho-Clinical Diagnostics, Inc.
Chemistry · 63d
Cleared Nov 17, 2004
SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT
K042459 · LCP
Beckman Coulter, Inc.
Chemistry · 68d
Cleared Nov 16, 2004
MULTI-CHEM CALIBRATOR A
K042551 · JIX
Wako Chemicals USA, Inc.
Chemistry · 57d
Cleared Nov 12, 2004
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS
K042291 · CEM
Beckman Coulter, Inc.
Chemistry · 80d
Cleared Nov 08, 2004
MULTI-LIPID CALIBRATOR
K042550 · JIX
Wako Chemicals USA, Inc.
Chemistry · 49d
Cleared Nov 08, 2004
MULTI CHEM CAL B
K042549 · JIX
Wako Chemicals USA, Inc.
Chemistry · 49d
Cleared Nov 05, 2004
MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
K042717 · JJX
Medical Analysis Systems, Inc.
Chemistry · 36d
Cleared Nov 03, 2004
ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)
K042307 · JIT
Seradyn, Inc.
Chemistry · 70d