ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801— 510(k) K072638

Name: FDA 510(k) clearance K072638
Creator: U.S. Food and Drug Administration
Published: 2007-10-19

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K072638 for ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801, Substantially Equivalent on 2007-10-19. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JGQ
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 2007-09-18
Decision date: 2007-10-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JGQ

view all

K131051 — HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)2013-06-07
K071239 — TOTAL PROTEIN URINE/CSF GEN.32007-09-14
K981295 — UPRO1998-10-01
K981682 — UPRO1998-09-21
K925794 — TRACE MICROPROTEIN REAGENT1993-03-29

More clearances from Roche Diagnostics Corp.

view all

K130138 — SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM2013-03-15
K101365 — ELECSYS CA 19-9 CALCHECK 52010-10-05
K100853 — COBAS 8000 MODULAR SERIES ANALYZER2010-09-09
K101196 — ACCU-CHEK ULTRFLEX INFUSION SET2010-08-27
K093664 — AMPHETAMINES II ASSAY2010-07-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.