The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for Lactate Dehydrogenase Ldh-l.
| Device ID | K874848 |
| 510k Number | K874848 |
| Device Name: | LACTATE DEHYDROGENASE LDH-L |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Applicant | TECH-CO, INC. 24111 BEVERLY Oak Park, MI 48237 |
| Contact | Happy Chen |
| Correspondent | Happy Chen TECH-CO, INC. 24111 BEVERLY Oak Park, MI 48237 |
| Product Code | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-24 |
| Decision Date | 1987-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486002072 | K874848 | 000 |
| 10673486002065 | K874848 | 000 |
| 00850053916137 | K874848 | 000 |