FDA 510(k) Premarket Notification K830679: URIC ACID COLORIMETRIC DETERMINATION

Submission Details & Decision

Normalized public record details for 510(k) notification K830679.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K830679

Applicant / Sponsor

Dow Instruments & Reagents, Inc.

Device Name

URIC ACID COLORIMETRIC DETERMINATION

Product Code

KNK

Decision Date

1983-04-06

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Traditional

Third Party Flag

Date Received

1983-03-04

Related Establishments / Registrations

SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
Fisher Diagnostics Registration: 1181121 View Registration
MEDICA CORP. Registration: 1220972 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319681 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319809 View Registration
STANBIO LABORATORY Registration: 1616487 View Registration
HORIBA INSTRUMENTS INCORPORATED Registration: 1827821 View Registration
TECO DIAGNOSTICS Registration: 1832216 View Registration
Carolina Liquid Chemistries Corp. Registration: 2030861 View Registration
BECKMAN COULTER, INC. Registration: 2050010 View Registration
BECKMAN COULTER, INC. Registration: 2050012 View Registration
CLINIQA CORPORATION Registration: 2085064 View Registration
ALFA WASSERMANN Registration: 2247288 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 2250051 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
ABAXIS, INC. Registration: 2939693 View Registration
HORIBA ABX SAS Registration: 3000148879 View Registration
Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration
Ortho Clinical Diagnostics Registration: 3002642396 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
Infrared Laboratory Systems dba SYNERMED Registration: 3003593973 View Registration
DIRUI INDUSTRIAL CO., LTD. Registration: 3003741796 View Registration
ROCHE DIAGNOSTICS INTERNATIONAL LTD. Registration: 3003795116 View Registration
RANDOX LABORATORIES LIMITED Registration: 3004493545 View Registration
ABBOTT IRELAND DIAGNOSTICS DIVISION Registration: 3005094123 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
MEDICON HELLAS SA Registration: 3006716639 View Registration
CHUNGDO PHARM. CO., LTD. Registration: 3007301207 View Registration
VitalScientific Registration: 3007662974 View Registration
CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD. Registration: 3008987086 View Registration
DIAFARMA ECZA DEPOSU VE MEDIKAL DIS TICARET DIS TIC LTD STI Registration: 3011989923 View Registration
Ortho Clinical Diagnostics, K.K. Registration: 3012963943 View Registration
High Technology, Inc. Registration: 3013660430 View Registration
BIOBASE BIODUSTRY(SHANDONG)CO., LTD Registration: 3014325803 View Registration
ABBOTT LABORATORIES Registration: 3016438761 View Registration
JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO LTD Registration: 3016859940 View Registration
HANGZHOU LYSUN BIOTECHNOLOGY CO.LTD Registration: 3021010433 View Registration
HOME HEALTH US INCORPORATED Registration: 3021186226 View Registration
BIALEX LAB Registration: 3021841051 View Registration
ASSURE TECH LLC Registration: 3030648160 View Registration
CHANGCHUN MERYDI BIO-TECH CO., LTD. Registration: 3038206980 View Registration
JILIN HONGYI BIO-TECH CO., LTD. Registration: 3043127699 View Registration
Sekisui Diagnostics P.E.I. Inc. Registration: 8020316 View Registration
WIENER LABORATORIOS S.A.I.C. Registration: 8040374 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610529 View Registration
Beckman Coulter Ireland Inc Registration: 9680746 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.