The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Reagent Set, Sgpt Serum Glutamic.
Device ID | K781726 |
510k Number | K781726 |
Device Name: | REAGENT SET, SGPT SERUM GLUTAMIC |
Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CKA |
CFR Regulation Number | 862.1030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-10-11 |
Decision Date | 1978-11-03 |