K871811 is an FDA 510(k) clearance for the SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA). This device is classified as a Cresolphthalein Complexone, Calcium (Class II - Special Controls, product code CIC).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 26, 1987, 18 days after receiving the submission on May 8, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K871811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 1987 |
| Decision Date | May 26, 1987 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CIC — Cresolphthalein Complexone, Calcium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1145 |