The following data is part of a premarket notification filed by Astoria-pacific,inc. with the FDA for Tyrosine 50-hour Reagent Kit.
| Device ID | K970093 |
| 510k Number | K970093 |
| Device Name: | TYROSINE 50-HOUR REAGENT KIT |
| Classification | 1-nitroso-2-naphthol (fluorometric), Free Tyrosine |
| Applicant | ASTORIA-PACIFIC,INC. 14600 S.E. 82ND DR. Clackamas, OR 97015 -0830 |
| Contact | Raymond L Pavitt |
| Correspondent | Raymond L Pavitt ASTORIA-PACIFIC,INC. 14600 S.E. 82ND DR. Clackamas, OR 97015 -0830 |
| Product Code | CDR |
| CFR Regulation Number | 862.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-10 |
| Decision Date | 1998-03-19 |
| Summary: | summary |