The following data is part of a premarket notification filed by Astoria-pacific,inc. with the FDA for Spotcheck Neonatal Galt Microplate Reagent Kit.
| Device ID | K102643 |
| 510k Number | K102643 |
| Device Name: | SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT |
| Classification | Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase |
| Applicant | ASTORIA-PACIFIC,INC. 15130 S.E. 82ND DR. Clackamas, OR 97015 |
| Contact | Jason C Reynolds |
| Correspondent | Jason C Reynolds ASTORIA-PACIFIC,INC. 15130 S.E. 82ND DR. Clackamas, OR 97015 |
| Product Code | KQP |
| CFR Regulation Number | 862.1315 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-14 |
| Decision Date | 2011-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00725609000267 | K102643 | 000 |
| 00725609000120 | K102643 | 000 |
| 00725609000113 | K102643 | 000 |