The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Nad Reduction Method, Lactate Pyrivate.
Device ID | K781724 |
510k Number | K781724 |
Device Name: | NAD REDUCTION METHOD, LACTATE PYRIVATE |
Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
Applicant | MEDICAL ANALYSIS SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CFJ |
CFR Regulation Number | 862.1440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-10-11 |
Decision Date | 1978-11-03 |