K873530 is an FDA 510(k) clearance for the PARAMAX MAGNESIUM REAGENT. This device is classified as a Photometric Method, Magnesium (Class I - General Controls, product code JGJ).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on December 14, 1987, 104 days after receiving the submission on September 1, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1495.
| 510(k) Number | K873530 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1987 |
| Decision Date | December 14, 1987 |
| Days to Decision | 104 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JGJ — Photometric Method, Magnesium |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1495 |