The following data is part of a premarket notification filed by American Research Products Co. with the FDA for Nad Reduction, Alt/spgt Codes 7722,7723,7422,7522.
Device ID | K901702 |
510k Number | K901702 |
Device Name: | NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522 |
Classification | Nadh Oxidation/nad Reduction, Alt/sgpt |
Applicant | AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
Contact | Patel, Ph.d. |
Correspondent | Patel, Ph.d. AMERICAN RESEARCH PRODUCTS CO. 30175 SOLON INDUSTRIAL PKWY. P.O. BOX 39098 Solon, OH 44139 |
Product Code | CKA |
CFR Regulation Number | 862.1030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-12 |
Decision Date | 1990-04-25 |