K822982 is an FDA 510(k) clearance for the MIDAS 100 HEMACOLOR STAIN #66030. This device is classified as a Eosin Y (Class I - General Controls, product code HYB).
Submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1982, 19 days after receiving the submission on October 8, 1982.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K822982 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 08, 1982 |
| Decision Date | October 27, 1982 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | HYB — Eosin Y |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.1850 |