The following data is part of a premarket notification filed by American Monitor Corp. with the FDA for Phosphorus Il.
| Device ID | K820832 |
| 510k Number | K820832 |
| Device Name: | PHOSPHORUS IL |
| Classification | 5-amp-phosphate Release (colorimetric Test), 5'-nucleotidase |
| Applicant | AMERICAN MONITOR CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CED |
| CFR Regulation Number | 862.1520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-26 |
| Decision Date | 1982-04-15 |