K861270 is an FDA 510(k) clearance for the BLUE RIBBON PARAFFIN INFILTRATION/EMBEDDING MED.. This device is classified as a Formulations, Paraffin, All (Class I - General Controls, product code KEO).
Submitted by Surgipath Medical Industries, Inc. (Grayslake, US). The FDA issued a Cleared decision on April 11, 1986, 7 days after receiving the submission on April 4, 1986.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.4010.
| 510(k) Number | K861270 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1986 |
| Decision Date | April 11, 1986 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KEO — Formulations, Paraffin, All |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.4010 |