K980028 is an FDA 510(k) clearance for the ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST). This device is classified as 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 February 2, 1998, 28 days after receiving the submission on January 5, 1998.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1030.
| 510(k) Number | K980028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 05, 1998 |
| Decision Date | February 02, 1998 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | CKA — Nadh Oxidation/nad Reduction, Alt/sgpt |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1030 |