The following data is part of a premarket notification filed by Sigma Chemical Co. with the FDA for Ldh (optimized) Reagent.
| Device ID | K860029 |
| 510k Number | K860029 |
| Device Name: | LDH (OPTIMIZED) REAGENT |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Applicant | SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Mathew Madappally, |
| Correspondent | Mathew Madappally, SIGMA CHEMICAL CO. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-06 |
| Decision Date | 1986-02-06 |