The following data is part of a premarket notification filed by Diagnostic Chemicals, Ltd. (usa) with the FDA for Lactate Dehydrogenase Cat. # 320-68, 320-69.
| Device ID | K875206 |
| 510k Number | K875206 |
| Device Name: | LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Applicant | DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe, CT 06468 |
| Contact | Karen Callbeck |
| Correspondent | Karen Callbeck DIAGNOSTIC CHEMICALS, LTD. (USA) 435 MAIN ST. Monroe, CT 06468 |
| Product Code | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-18 |
| Decision Date | 1988-02-02 |