The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Lactate Dehydrogenase (l-p).
| Device ID | K905683 |
| 510k Number | K905683 |
| Device Name: | BIOTROL LACTATE DEHYDROGENASE (L-P) |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Applicant | BIOTROL, USA, INC. 113 BRANYWINE PKWY. Westchester, PA 19380 |
| Contact | Allan C Murphy |
| Correspondent | Allan C Murphy BIOTROL, USA, INC. 113 BRANYWINE PKWY. Westchester, PA 19380 |
| Product Code | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-19 |
| Decision Date | 1991-03-11 |