The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Ldh Reagent Kit.
| Device ID | K903773 |
| 510k Number | K903773 |
| Device Name: | SYNERMED LDH REAGENT KIT |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Applicant | SYNERMED, INC. 445 BOUL. INDUSTRIEL ST-EUSTANCHE Quebec, CA J745r3 |
| Contact | Marcia Arentz |
| Correspondent | Marcia Arentz SYNERMED, INC. 445 BOUL. INDUSTRIEL ST-EUSTANCHE Quebec, CA J745r3 |
| Product Code | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-20 |
| Decision Date | 1990-10-12 |