K780214 is an FDA 510(k) clearance for the HEMO FEC. This device is classified as a Reagent, Occult Blood (Class II - Special Controls, product code KHE).
Submitted by Boehringer Mannheim Corp. (Mchenry, US). The FDA issued a Cleared decision on May 3, 1978, 84 days after receiving the submission on February 8, 1978.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K780214 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 1978 |
| Decision Date | May 03, 1978 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KHE — Reagent, Occult Blood |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6550 |