The following data is part of a premarket notification filed by Biochemicals, Inc. with the FDA for Phenylalanine Uv Kinetic Test Kit.
| Device ID | K813171 |
| 510k Number | K813171 |
| Device Name: | PHENYLALANINE UV KINETIC TEST KIT |
| Classification | Ninhydrin And L-leucyl-l-alanine (fluorimetric), Phenylalanine |
| Applicant | BIOCHEMICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JNB |
| CFR Regulation Number | 862.1555 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-16 |
| Decision Date | 1981-12-03 |