The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Nicotinamide-adenine Ainucleotide (nad).
Device ID | K790248 |
510k Number | K790248 |
Device Name: | NICOTINAMIDE-ADENINE AINUCLEOTIDE (NAD) |
Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
Applicant | BOEHRINGER LABORATORIES 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 | 1979-02-08 |
Decision Date | 1979-04-04 |