The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Uni-fast Lactate Dehydrogenase (ldh-l).
| Device ID | K872030 |
| 510k Number | K872030 |
| Device Name: | UNI-FAST LACTATE DEHYDROGENASE (LDH-L) |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Applicant | SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Contact | King, Ph.d. |
| Correspondent | King, Ph.d. SCLAVO, INC. 5 MANSARD COURT Wayne, NJ 07470 |
| Product Code | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-26 |
| Decision Date | 1987-07-07 |