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 |