Cleared Traditional

LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET

K003030 · Bio-Rad · Hematology
Nov 2000
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K003030 is an FDA 510(k) clearance for the LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET, a Control, Hemoglobin (Class II — Special Controls, product code GGM), submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on November 29, 2000, 62 days after receiving the submission on September 28, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K003030 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2000
Decision Date November 29, 2000
Days to Decision 62 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