The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Spin Chem Reagent, Determination Of Ldh-.
| Device ID | K791081 |
| 510k Number | K791081 |
| Device Name: | SPIN CHEM REAGENT, DETERMINATION OF LDH- |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Applicant | SMITH KLINE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CFJ |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-12 |
| Decision Date | 1979-07-17 |