The following data is part of a premarket notification filed by Analytical & Research Chemicals, Inc. with the FDA for Alp Test.
Device ID | K781324 |
510k Number | K781324 |
Device Name: | ALP TEST |
Classification | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes |
Applicant | ANALYTICAL & RESEARCH CHEMICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CIO |
CFR Regulation Number | 862.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-07-31 |
Decision Date | 1978-08-31 |