The following data is part of a premarket notification filed by P-l Biochemicals, Inc. with the FDA for Phe/tyr Kinetic Uv Test Set.
| Device ID | K813449 |
| 510k Number | K813449 |
| Device Name: | PHE/TYR KINETIC UV TEST SET |
| Classification | Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine |
| Applicant | P-L BIOCHEMICALS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JNB |
| CFR Regulation Number | 862.1555 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-10 |
| Decision Date | 1981-12-31 |