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
3265–3288 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 01, 2002
SPECTRAL'S TROPONIN I
K014105 · MMI
Spectral Diagnostics, Inc.
Chemistry · 50d
Cleared Feb 01, 2002
VACUETTE EDTA K2 TUBES
K014104 · PJE
Greiner Vacuette North America, Inc.
Chemistry · 50d
Cleared Feb 01, 2002
ROCHE COBAS TAQMAN ANALYZER
K012966 · JJF
Roche Molecular Systems, Inc.
Chemistry · 150d
Cleared Jan 29, 2002
CORTISOL LIA
K010790 · CGR
Kmi Diagnostics, Inc.
Chemistry · 320d
Cleared Jan 28, 2002
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
K014103 · MRR
Beckman Coulter, Inc.
Chemistry · 46d
Cleared Jan 28, 2002
WIENER LAB. ALP 405
K013983 · CJE
Wiener Laboratories Saic
Chemistry · 56d
Cleared Jan 28, 2002
IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE
K013938 · KHP
Diametrics Medical, Inc.
Chemistry · 61d
Cleared Jan 22, 2002
AIMSTEP PREGNANCY
K013857 · DHA
Germaine Laboratories, Inc.
Chemistry · 62d
Cleared Jan 18, 2002
CREATINE KINASE (CK-NAC)
K013912 · CGS
Jas Diagnostics, Inc.
Chemistry · 52d
Cleared Jan 18, 2002
AUTION MAX AX-4280 URINALYSIS SYSTEM
K013783 · KQO
International Remote Imaging Systems
Chemistry · 65d
Cleared Jan 18, 2002
ADVIA 1650 CHOLINESTERASE ASSAY
K013750 · DIH
Bayer Diagnostics Corp.
Chemistry · 66d
Cleared Jan 18, 2002
N LATEX LP(A)
K013128 · DFC
Dade Behring, Inc.
Chemistry · 121d
Cleared Jan 18, 2002
THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG...
K012943 · NAL
Quantech , Ltd.
Chemistry · 140d
Cleared Jan 17, 2002
MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
K012789 · JHO
Morax
Chemistry · 150d
Cleared Jan 17, 2002
RANDOX THEOPHYLLINE
K011771 · KLS
Randox Laboratories, Ltd.
Chemistry · 225d
Cleared Jan 15, 2002
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
K013978 · JFJ
Beckman Coulter, Inc.
Chemistry · 43d
Cleared Jan 15, 2002
STAT PROFILE PHOX BASIC ANALYZER
K013729 · CHL
Nova Biomedical Corp.
Chemistry · 67d
Cleared Jan 08, 2002
BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT
K013062 · MMI
Biocheck, Inc.
Chemistry · 118d
Cleared Jan 08, 2002
WAMPOLE HS-CRP ELISA
K011855 · DCN
Carter-Wallace, Inc.
Chemistry · 209d
Cleared Dec 27, 2001
VICTORCH HCG TEST STRIP
K013702 · JHI
Victorch Meditek, Inc.
Chemistry · 49d
Cleared Dec 27, 2001
VICTORCH MEDITEK'S HCG TEST CARD
K013678 · DHA
Victorch Meditek, Inc.
Chemistry · 50d
Cleared Dec 21, 2001
BIOSCANNER PLUS
K014099 · NBW
Polymer Technology Systems, Inc.
Chemistry · 8d
Cleared Dec 21, 2001
MODIFICATION TO MAS CARDIOLMMUNE TL
K013995 · JJY
Medical Analysis Systems, Inc.
Chemistry · 17d
Cleared Dec 21, 2001
STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE
K013850 · JIT
Diamond Diagnostics, Inc.
Chemistry · 31d