Cleared Traditional

R&D SICKLE QC CONTROL

K070334 · R&D Systems, Inc. · Hematology
Mar 2007
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K070334 is an FDA 510(k) clearance for the R&D SICKLE QC CONTROL, a Control, Hemoglobin (Class II — Special Controls, product code GGM), submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 29, 2007, 52 days after receiving the submission on February 5, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K070334 FDA.gov
FDA Decision Cleared SESE
Date Received February 05, 2007
Decision Date March 29, 2007
Days to Decision 52 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGM — Control, Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625

Similar Devices — GGM Control, Hemoglobin

All 14
HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
K192842 · Eurotrol B.V. · Nov 2019
HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
K182744 · Eurotrol B.V. · Feb 2019
LYPHOCHEK DIABETES CONTROL
K070546 · Bio-Rad Laboratories · Apr 2007
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
K052838 · Bio-Rad · Nov 2005
GLYCOHEMOSURE HBA1C CONTROL
K032791 · Quantimetrix Corp. · Oct 2003
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
K003030 · Bio-Rad · Nov 2000