The following data is part of a premarket notification filed by Princeton Biomedix with the FDA for Test, Acid Phosphatase.
Device ID | K760161 |
510k Number | K760161 |
Device Name: | TEST, ACID PHOSPHATASE |
Classification | Acid Phosphatase, Thymol Blue Monophosphate |
Applicant | PRINCETON BIOMEDIX 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CJR |
CFR Regulation Number | 862.1020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-02 |
Decision Date | 1976-07-20 |