The following data is part of a premarket notification filed by Astoria-pacific,inc. with the FDA for Uridyltransferase Kit, 50 Hour (80-4000-13k).
| Device ID | K970277 |
| 510k Number | K970277 |
| Device Name: | URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K) |
| Classification | Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase |
| 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 | KQP |
| CFR Regulation Number | 862.1315 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-23 |
| Decision Date | 1997-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00725609000182 | K970277 | 000 |
| 00725609000175 | K970277 | 000 |
| 00725609000168 | K970277 | 000 |
| 00725609000151 | K970277 | 000 |
| 00725609000069 | K970277 | 000 |
| 00725609000052 | K970277 | 000 |
| 00725609000045 | K970277 | 000 |