The following data is part of a premarket notification filed by Alpkem Corp. with the FDA for Magnesium (substrate, Enzyme, Reagent).
| Device ID | K860367 |
| 510k Number | K860367 |
| Device Name: | MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) |
| Classification | Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes |
| Applicant | ALPKEM CORP. BOX 1260 Clackamas, OR 97015 |
| Contact | William H Souder |
| Correspondent | William H Souder ALPKEM CORP. BOX 1260 Clackamas, OR 97015 |
| Product Code | JGF |
| CFR Regulation Number | 862.1445 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-03 |
| Decision Date | 1986-04-11 |