K881598 is an FDA 510(k) clearance for the SDL TRICHROME STAIN. This device is classified as a Stains, Microbiologic (Class I - General Controls, product code JTS).
Submitted by Scientific Device Laboratory, Inc. (Glenview, US). The FDA issued a Cleared decision on May 4, 1988, 21 days after receiving the submission on April 13, 1988.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K881598 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 1988 |
| Decision Date | May 04, 1988 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | JTS — Stains, Microbiologic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.1850 |