GLYCOHEMOSURE HBA1C CONTROL— 510(k) K032791

Substantially Equivalent

Quantimetrix Corp.

FDA 510(k) clearance K032791 for GLYCOHEMOSURE HBA1C CONTROL, Substantially Equivalent on 2003-10-30. Applicant: Quantimetrix Corp.. Device class: 2.

Clearance details

Applicant: Quantimetrix Corp.
Product code: Code GGM
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 2003-09-08
Decision date: 2003-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redondo Beach, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGM

K192842 — HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High2019-11-15
K182744 — HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High2019-02-01
K070546 — LYPHOCHEK DIABETES CONTROL2007-04-02
K070334 — R&D SICKLE QC CONTROL2007-03-29
K052838 — LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,42005-11-09

More clearances from Quantimetrix Corp.

K142262 — AUTION CHECK PLUS2015-04-10
K113177 — COMPLETE D 25-OH VITAMIN D CONTROL2012-05-10
K103744 — DROPPER A1C DIABETES CONTROL2011-05-12
K062942 — QUANTIMETRIX NICOSURE COTININE URINE CONTROL2006-10-30
K062751 — MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER2006-10-03

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