The following data is part of a premarket notification filed by Anco Medical Reagents & Assoc. with the FDA for Megnesium Reagent Kit.
Device ID | K821102 |
510k Number | K821102 |
Device Name: | MEGNESIUM REAGENT KIT |
Classification | Photometric Method, Magnesium |
Applicant | ANCO MEDICAL REAGENTS & ASSOC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JGJ |
CFR Regulation Number | 862.1495 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-20 |
Decision Date | 1982-05-05 |