The following data is part of a premarket notification filed by Omega Medical Electronics with the FDA for Alkaline Phosphotase Reagent Set.
Device ID | K821200 |
510k Number | K821200 |
Device Name: | ALKALINE PHOSPHOTASE REAGENT SET |
Classification | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes |
Applicant | OMEGA MEDICAL ELECTRONICS 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 | 1982-04-27 |
Decision Date | 1982-07-13 |