The following data is part of a premarket notification filed by Alpkem Corp. with the FDA for Total Galactose.
| Device ID | K894011 |
| 510k Number | K894011 |
| Device Name: | TOTAL GALACTOSE |
| Classification | Fluorescent Proc. (qual.), Galactose-1-phosphate Uridyl Transferase |
| Applicant | ALPKEM CORP. BOX 1260 Clackamas, OR 97015 |
| Contact | Raymond L Pavitt |
| Correspondent | Raymond L Pavitt ALPKEM CORP. BOX 1260 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 | 1989-06-06 |
| Decision Date | 1990-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00725609000014 | K894011 | 000 |