K852136 is an FDA 510(k) clearance for the PRECINORM HB. This device is classified as a Control, Hemoglobin (Class II - Special Controls, product code GGM).
Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 5, 1985, 50 days after receiving the submission on May 16, 1985.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K852136 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 1985 |
| Decision Date | July 05, 1985 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GGM — Control, Hemoglobin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8625 |