The following data is part of a premarket notification filed by Astoria-pacific,inc. with the FDA for Spotcheck Blood Spot Control, Assayed.
| Device ID | K090940 |
| 510k Number | K090940 |
| Device Name: | SPOTCHECK BLOOD SPOT CONTROL, ASSAYED |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | ASTORIA-PACIFIC,INC. 15130 S.E. 82ND DR. Clackamas, OR 97015 |
| Contact | Charles A Peterson |
| Correspondent | Charles A Peterson ASTORIA-PACIFIC,INC. 15130 S.E. 82ND DR. Clackamas, OR 97015 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-03 |
| Decision Date | 2009-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00725609000458 | K090940 | 000 |
| 00725609000441 | K090940 | 000 |
| 00725609000212 | K090940 | 000 |
| 00725609000205 | K090940 | 000 |