K800239 is an FDA 510(k) clearance for the RH-HR NEGATIVE CONTROL REAGENT. This device is classified as a Kit, Quality Control For Blood Banking Reagents (Class II - Special Controls, product code KSF).
Submitted by Gotham Biologics, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1980, 16 days after receiving the submission on February 5, 1980.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9650.
| 510(k) Number | K800239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1980 |
| Decision Date | February 21, 1980 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KSF — Kit, Quality Control For Blood Banking Reagents |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9650 |