K812846 is an FDA 510(k) clearance for the CLEAR-RITE II. This device is classified as a Agent, Clearing (Class I - General Controls, product code KEM).
Submitted by Richard-Allan Medical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on October 29, 1981, 20 days after receiving the submission on October 9, 1981.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.4010.
| 510(k) Number | K812846 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 1981 |
| Decision Date | October 29, 1981 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KEM — Agent, Clearing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.4010 |