Hemoglobin Controls

FDA 510(k) K790310 · Electrophoresis Corp.

Substantially Equivalent

510(k) numberK790310

Submission

Device name
Hemoglobin Controls
Applicant
Electrophoresis Corp.
Mchenry, IL, US
Received
February 13, 1979
Decision date
March 21, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GGM – Control, Hemoglobin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.8625
Specialty
Hematology

Other 510(k)s with product code GGM

510(k)DeviceApplicantDecision
K192842HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighGGM · Traditional Eurotrol B.V.11/15/2019SE
K182744HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighGGM · Traditional Eurotrol B.V.02/01/2019SE
K070546Lyphochek Diabetes ControlGGM · Traditional Bio-Rad Laboratories04/02/2007SE
K070334R&D Sickle QC ControlGGM · Traditional R&D Systems, Inc.03/29/2007SE
K052838Liquichek Diabetes Control, Level 1,2,3,4GGM · Traditional Bio-Rad11/09/2005SE
K032791Glycohemosure HBA1C ControlGGM · Traditional Quantimetrix Corp.10/30/2003SE
K003030Lyphochek Hemoglobin Alc Linearity SetGGM · Traditional Bio-Rad11/29/2000SE
K993321R&D Hgb/Glc Whole Blood ControlGGM · Traditional R&D Systems, Inc.11/12/1999SE
K964052Hemocue HemotrolGGM · Traditional Direct Solutions11/06/1996SE
K963908Hemocue HemolinGGM · Traditional Direct Solutions10/16/1996SE

More from Direct Solutions

510(k)DeviceDecision
K802395Special Procedure Aqarose FilmJJN · Traditional 11/26/1980SE
K790309CPK Isoenzyme SubstrateJHY · Traditional 04/04/1979SE
K790311LDH Isoenzyme ReagentCFE · Traditional 03/21/1979SE

Questions and answers

When was Hemoglobin Controls cleared by the FDA?

Hemoglobin Controls (K790310) received a 510(k) decision of Substantially Equivalent on March 21, 1979, 36 days after the submission was received.

What is the product code of K790310?

The FDA product code is GGM – Control, Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.8625.