K970093 is an FDA 510(k) clearance for the TYROSINE 50-HOUR REAGENT KIT. This device is classified as a 1-nitroso-2-naphthol (fluorometric), Free Tyrosine (Class I - General Controls, product code CDR).
Submitted by Astoria-Pacific, Inc. (Clackamas, US). The FDA issued a Cleared decision on March 19, 1998, 433 days after receiving the submission on January 10, 1997.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1730.
| 510(k) Number | K970093 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 10, 1997 |
| Decision Date | March 19, 1998 |
| Days to Decision | 433 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CDR — 1-nitroso-2-naphthol (fluorometric), Free Tyrosine |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1730 |