Submission Details
| 510(k) Number | K810684 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 13, 1981 |
| Decision Date | April 08, 1981 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
Cleared
Traditional
K810684 - HEMOCOLOR STAIN SET
(FDA 510(k) Clearance)
Apr 1981
Decision
26d
Days
Class 1
Risk
K810684 is an FDA 510(k) clearance for the HEMOCOLOR STAIN SET, a Eosin B (Class I — General Controls, product code ICC), submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on April 8, 1981, 26 days after receiving the submission on March 13, 1981. This device falls under the Microbiology review panel. Regulated under 21 CFR 864.1850.
Device Classification
| Product Code | ICC — Eosin B |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 864.1850 |