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 |