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
2593–2616 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 25, 2005
MOMENTS MENOPAUSE CHECK, MODEL 9113
K043599 · CGJ
Phamatech, Inc.
Chemistry · 58d
Cleared Feb 15, 2005
SPOTCHEM II CALCIUM, MAGNESIUM, AND BLOOD UREA NITROGEN TESTS
K050077 · CIC
Arkray, Inc.
Chemistry · 34d
Cleared Feb 15, 2005
STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK...
K043476 · NBC
Dade Behring, Inc.
Chemistry · 61d
Cleared Feb 15, 2005
SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2
K043268 · CEI
Randox Laboratories, Ltd.
Chemistry · 81d
Cleared Feb 15, 2005
RANDOX URINE CONTROLS
K043266 · JJW
Randox Laboratories, Ltd.
Chemistry · 81d
Cleared Feb 15, 2005
PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240
K040958 · JJE
Tokyo Boeki Medical System , Ltd.
Chemistry · 308d
Cleared Feb 10, 2005
POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2
K043267 · CEJ
Randox Laboratories, Ltd.
Chemistry · 76d
Cleared Feb 09, 2005
CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
K050202 · CGR
Beckman Coulter, Inc.
Chemistry · 12d
Cleared Feb 09, 2005
ALCOHAWK PRECISION
K043188 · DJZ
Q3 Innovations, LLC
Chemistry · 84d
Cleared Feb 08, 2005
LIQUICHEK BNP CONTROL
K043584 · JJX
Bio-Rad Laboratories, Inc.
Chemistry · 42d
Cleared Feb 08, 2005
ADVIA IMS CARBAMAZEPINE METHOD
K042808 · KLT
Bayer Healthcare, LLC
Chemistry · 119d
Cleared Feb 08, 2005
ADVIA IMS VALPROIC ACID METHOD
K042807 · LEG
Bayer Healthcare, LLC
Chemistry · 119d
Cleared Feb 07, 2005
VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM...
K043384 · LDO
Ortho-Clinical Diagnostics, Inc.
Chemistry · 60d
Cleared Feb 07, 2005
QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121
K043051 · DJG
Phamatech, Inc.
Chemistry · 95d
Cleared Jan 31, 2005
PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC
K050026 · JIX
Roche Diagnostics
Chemistry · 25d
Cleared Jan 31, 2005
OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071
K043460 · JIX
Olympus America, Inc.
Chemistry · 47d
Cleared Jan 27, 2005
RANDOX PHENCYCLIDINE ASSAY
K043071 · LCM
Randox Laboratories, Ltd.
Chemistry · 80d
Cleared Jan 26, 2005
LDL-EX SEIKEN ASSAY KIT
K043264 · MRR
Denka Seiken Co., Ltd.
Chemistry · 63d
Cleared Jan 24, 2005
ARCHITECT STAT MYO IMMUNOASSAY
K042924 · DDR
Fisher Diagnostics
Chemistry · 94d
Cleared Jan 18, 2005
DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE
K043546 · CDT
Dade Behring, Inc.
Chemistry · 26d
Cleared Jan 10, 2005
ROCHE AMPLICHIP CYP450 TEST
K043576 · NTI
Roche Molecular Systems, Inc.
Chemistry · 14d
Cleared Jan 07, 2005
LIQUID ASSAYED MULTIQUAL CONTROL
K043208 · JJY
Bio-Rad
Chemistry · 49d
Cleared Jan 07, 2005
CHEMVIEW-10
K042641 · JIL
Cenogenics Corp.
Chemistry · 102d
Cleared Jan 03, 2005
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
K042678 · NBW
Bionime Corporation
Chemistry · 96d