The following data is part of a premarket notification filed by Alpkem Corp. with the FDA for Phenylalanine (ninhydrin Reaction).
| Device ID | K891070 |
| 510k Number | K891070 |
| Device Name: | PHENYLALANINE (NINHYDRIN REACTION) |
| Classification | Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine |
| 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 | JNB |
| CFR Regulation Number | 862.1555 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-01 |
| Decision Date | 1989-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00725609000007 | K891070 | 000 |