K771699 is an FDA 510(k) clearance for the CARA-STAIN MODEL 3000. This device is classified as a Slide Stainer, Automated (Class I - General Controls, product code KPA).
Submitted by American Safety Equipment Corp. (Mchenry, US). The FDA issued a Cleared decision on September 13, 1977, 7 days after receiving the submission on September 6, 1977.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.3800.
| 510(k) Number | K771699 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1977 |
| Decision Date | September 13, 1977 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KPA — Slide Stainer, Automated |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.3800 |