The following data is part of a premarket notification filed by Astoria-pacific,inc. with the FDA for Spotcheck Neonatal Total Galactose Microplate Reagent Kit.
| Device ID | K121101 |
| 510k Number | K121101 |
| Device Name: | SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT |
| Classification | Enzymatic Methods, Galactose |
| 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 | JIA |
| CFR Regulation Number | 862.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-11 |
| Decision Date | 2013-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00725609000106 | K121101 | 000 |
| 00725609000090 | K121101 | 000 |