Submission Details
| 510(k) Number | K973869 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 24, 1997 |
| Decision Date | January 07, 1998 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
Cleared
Traditional
TRACE REAGENT LINE FOR THE COBAS MIRA
Jan 1998
Decision
105d
Days
Class 1
Risk
About This 510(k) Submission
K973869 is an FDA 510(k) clearance for the TRACE REAGENT LINE FOR THE COBAS MIRA, a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I — General Controls, product code CKA), submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on January 7, 1998, 105 days after receiving the submission on September 24, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.
Device Classification
| Product Code | CKA — Nadh Oxidation/nad Reduction, Alt/sgpt |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1030 |
Manufacturer
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