K881104 is an FDA 510(k) clearance for the PARAMAX IRON REAGENT. This device is classified as a Photometric Method, Iron (non-heme) (Class I - General Controls, product code JIY).
Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on April 28, 1988, 44 days after receiving the submission on March 15, 1988.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1410.
| 510(k) Number | K881104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 15, 1988 |
| Decision Date | April 28, 1988 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JIY — Photometric Method, Iron (non-heme) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1410 |