The following data is part of a premarket notification filed by Astoria-pacific,inc. with the FDA for Astoria-pacific Spotcheck Biotinidase Microplate Reagent Kit.
| Device ID | K080294 |
| 510k Number | K080294 |
| Device Name: | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT |
| Classification | System, Test, Biotinidase |
| Applicant | ASTORIA-PACIFIC,INC. 15130 S.E. 82ND DR. Clackamas, OR 97015 |
| Contact | Jason Reynolds |
| Correspondent | Jason Reynolds ASTORIA-PACIFIC,INC. 15130 S.E. 82ND DR. Clackamas, OR 97015 |
| Product Code | NAK |
| CFR Regulation Number | 862.1118 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-04 |
| Decision Date | 2008-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00725609000144 | K080294 | 000 |
| 00725609000137 | K080294 | 000 |