The following data is part of a premarket notification filed by Catachem, Inc. with the FDA for Lactate Dehydrogenase (ld) For Cont. Flow Instrum..
| Device ID | K860713 |
| 510k Number | K860713 |
| Device Name: | LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Applicant | CATACHEM, INC. 6 NORTH PEARL ST. Port Chester, NY 10573 |
| Contact | Luis P Leon |
| Correspondent | Luis P Leon CATACHEM, INC. 6 NORTH PEARL ST. Port Chester, NY 10573 |
| Product Code | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-26 |
| Decision Date | 1986-04-24 |