TRACE REAGENT LINE FOR THE COBAS MIRA

Nadh Oxidation/nad Reduction, Alt/sgpt

TRACE AMERICA, INC.

The following data is part of a premarket notification filed by Trace America, Inc. with the FDA for Trace Reagent Line For The Cobas Mira.

Pre-market Notification Details

• Device ID: K973869
• 510k Number: K973869
• Device Name: TRACE REAGENT LINE FOR THE COBAS MIRA
• Classification: Nadh Oxidation/nad Reduction, Alt/sgpt
• Applicant: TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. Miami, FL 33166
• Contact: David Johnston
• Correspondent: David Johnston; TRACE AMERICA, INC. 7260 NORTH WEST 58TH ST. Miami, FL 33166
• Product Code: CKA
• Subsequent Product Code: CDQ
• Subsequent Product Code: CEK
• Subsequent Product Code: CGX
• Subsequent Product Code: CHH
• Subsequent Product Code: CIG
• Subsequent Product Code: CIT
• Subsequent Product Code: JFJ
• Subsequent Product Code: JGY
• Subsequent Product Code: JIY
• Subsequent Product Code: JMO
• Subsequent Product Code: KHS
• Subsequent Product Code: KNK
• CFR Regulation Number: 862.1030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-09-24
• Decision Date: 1998-01-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00845275003031	K973869	000
00845275002973	K973869	000
00845275000351	K973869	000
00845275000047	K973869	000