Gamma Smac Reagents

FDA 510(k) K790578 · Gamma Enterprises, Inc.

Substantially Equivalent

510(k) numberK790578

Submission

Device name
Gamma Smac Reagents
Applicant
Gamma Enterprises, Inc.
Mchenry, IL, US
Received
March 27, 1979
Decision date
May 15, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CIG – Diazo Colorimetry, Bilirubin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1110
Specialty
Clinical Chemistry

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K222104Atellica® CH Diazo Total Bilirubin (D_TBil)CIG · Traditional Siemens Healthcare Diagnostics, Inc.03/20/2023SE
K223324Total Bilirubin2CIG · Traditional Abbott Ireland Diagnostics Division12/29/2022SE
K190807VITROS XT Chemistry Products TBIL-ALKP SlidesCIG · Traditional Ortho-Clinical Diagnostics, Inc.04/26/2019SE
K171401ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT…CIG · Traditional Elitechgroup07/11/2017SE
K150510Total BilirubinCIG · Traditional Abbott Laboratories04/02/2015SE
K131544Cobas C Bilirubin Total GEN.3CIG · Traditional Roche Diagnostics07/17/2013SE
K131217S Test Reagent Cartridge Total BilirubinCIG · Traditional Hitachi Chemical Diagnostics, Inc.06/07/2013SE
K123802Easyra Tbil Reagent, Easyra Dbii Reagent, Easyra CK ReagentCIG · Traditional Medica Corp.03/01/2013SE

More from Medica Corp.

510(k)DeviceDecision
K780507Serum Glutamic-Pyruvic TransaminaseCKC · Traditional 05/03/1978SE
K780506Carbon Dioxide ReagentsKMS · Traditional 05/03/1978SE
K780505Serum Glutamic-Oxaloacetic-TransaminaseCIT · Traditional 05/03/1978SE
K780504Creatine Phosphokinase (CPK)JHS · Traditional 05/03/1978SE
K771843Wetting Agents · Traditional 11/22/1977SE
K771836Lactate DehydrogenaseCFJ · Traditional 11/22/1977SE
K771832ChlorideJFS · Traditional 11/22/1977SE
K771838Serum IronJIY · Traditional 11/03/1977SE
K771834CreatinineCGX · Traditional 11/03/1977SE
K771839SodiumJGS · Traditional 11/02/1977SE

Questions and answers

When was Gamma Smac Reagents cleared by the FDA?

Gamma Smac Reagents (K790578) received a 510(k) decision of Substantially Equivalent on May 15, 1979, 49 days after the submission was received.

What is the product code of K790578?

The FDA product code is CIG – Diazo Colorimetry, Bilirubin, a Class II (moderate risk) device regulated under 21 CFR 862.1110.