The following data is part of a premarket notification filed by Synermed, Inc. with the FDA for Synermed Ldhh-l Reagent Kit.
| Device ID | K921025 |
| 510k Number | K921025 |
| Device Name: | SYNERMED LDHH-L REAGENT KIT |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Applicant | SYNERMED, INC. 1688 50TH AVENUE, MONTREAL (LACHINE), Quebec, Canada, CA H8t 2v5 |
| Contact | Marcia J Arentz |
| Correspondent | Marcia J Arentz SYNERMED, INC. 1688 50TH AVENUE, MONTREAL (LACHINE), Quebec, Canada, CA H8t 2v5 |
| Product Code | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-03 |
| Decision Date | 1992-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060500091910 | K921025 | 000 |
| 05060500091156 | K921025 | 000 |
| 05060500091149 | K921025 | 000 |
| 05060500091132 | K921025 | 000 |
| 05060500091125 | K921025 | 000 |
| 05060500091118 | K921025 | 000 |
| 05060500091101 | K921025 | 000 |