Cleared Traditional

R&D HGB/GLC WHOLE BLOOD CONTROL

K993321 · R&D Systems, Inc. · Hematology
Nov 1999
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K993321 is an FDA 510(k) clearance for the R&D HGB/GLC WHOLE BLOOD 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 November 12, 1999, 39 days after receiving the submission on October 4, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K993321 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 1999
Decision Date November 12, 1999
Days to Decision 39 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
R&D SICKLE QC CONTROL
K070334 · R&D Systems, Inc. · Mar 2007
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
K052838 · Bio-Rad · Nov 2005
GLYCOHEMOSURE HBA1C CONTROL
K032791 · Quantimetrix Corp. · Oct 2003