K823363 is an FDA 510(k) clearance for the COUNT-10 STAIN. This device is classified as a Stains, Dye Solution (Class I - General Controls, product code LEE).
Submitted by V-Tech, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 15, 1982, 36 days after receiving the submission on November 9, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K823363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 1982 |
| Decision Date | December 15, 1982 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LEE — Stains, Dye Solution |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.1850 |