K892838 is an FDA 510(k) clearance for the IRON SYSTEM PACK REAGENTS. This device is classified as a Photometric Method, Iron (non-heme) (Class I - General Controls, product code JIY).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on June 16, 1989, 59 days after receiving the submission on April 18, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1410.
| 510(k) Number | K892838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 1989 |
| Decision Date | June 16, 1989 |
| Days to Decision | 59 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 |