The following data is part of a premarket notification filed by Anco Medical Reagents & Assoc. with the FDA for Ldh Reagent Set.
| Device ID | K812836 |
| 510k Number | K812836 |
| Device Name: | LDH REAGENT SET |
| Classification | Tetrazolium Int Dye-diaphorase, Lactate Dehydrogenase |
| Applicant | ANCO MEDICAL REAGENTS & ASSOC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CFH |
| CFR Regulation Number | 862.1440 [🔎] |
| Decision | Se - Postmarket Surveillance Required (SESP) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-09 |
| Decision Date | 1981-10-09 |