The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Kinetic Ldh, A< Blue 610 Method.
| Device ID | K840006 |
| 510k Number | K840006 |
| Device Name: | KINETIC LDH, A< BLUE 610 METHOD |
| Classification | Nad Reduction/nadh Oxidation, Lactate Dehydrogenase |
| Applicant | AMERICAN MONITOR CORP. 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 | 1984-01-04 |
| Decision Date | 1984-03-23 |