Smac Sys., Supplemental Products for

Q: What is the product code of K771033?

The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.

FDA 510(k) K771033 · Mid Tech, Inc.

Substantially Equivalent

510(k) numberK771033

Submission

Device name: Smac Sys., Supplemental Products for
Applicant: Mid Tech, Inc.
Mchenry, IL, US
Received: June 9, 1977
Decision date: August 4, 1977
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt
Device class: Class I (low risk)
Regulation: 21 CFR 862.1030
Specialty: Clinical Chemistry

Other 510(k)s with product code CKA

510(k)	Device	Applicant	Decision
K120945	Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test…CKA · Traditional	Hitachi Chemical Diagnostics, Inc.	06/07/2013SE
K113382	Ace Alt ReagentCKA · Traditional	Alfa Wassermann	07/19/2012SE
K061020	Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase…CKA · Special	Dade Behring, Inc.	05/10/2006SE
K020487	Careside AltCKA · Traditional	Careside, Inc.	06/04/2002SE
K980028	Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)CKA · Traditional	Trace America, Inc.	02/02/1998SE
K973869	Trace Reagent Line for the Cobas MiraCKA · Traditional	Trace America, Inc.	01/07/1998SE
K974003	Alanine Aminotransferase-Sl Assay Catalogue Number 318-10, 318-30CKA · Traditional	Diagnostic Chemicals , Ltd.	12/05/1997SE
K971323	Alt or SGPTCKA · Traditional	Carolina Liquid Chemistries Corp.	04/21/1997SE
K965134	Alt/SgptCKA · Traditional	Derma Media Lab., Inc.	02/18/1997SE
K961123	Alt Incorporating DSTCKA · Traditional	Trace Scientific , Ltd.	04/25/1996SE

More from Trace Scientific , Ltd.

510(k)	Device	Decision
K810951	Reagents for Quant. Enzymatic Deter.-Tr. · Traditional	04/23/1981SE
K791869	Glucose Oxidase (Frinder) KitCGA · Traditional	10/01/1979SE
K791313	Ars, ChemistryJJY · Traditional	08/16/1979SE
K770508	Smac SystemJCC · Traditional	05/09/1977SE

Questions and answers

When was Smac Sys., Supplemental Products for cleared by the FDA?

Smac Sys., Supplemental Products for (K771033) received a 510(k) decision of Substantially Equivalent on August 4, 1977, 56 days after the submission was received.

What is the product code of K771033?

The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.