K890984 is an FDA 510(k) clearance for the LINISTAIN SLS. This device is classified as a Slide Stainer, Immersion Type (Class I - General Controls, product code KIO).
Submitted by Shandon, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on April 4, 1989, 36 days after receiving the submission on February 27, 1989.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3800.
| 510(k) Number | K890984 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1989 |
| Decision Date | April 04, 1989 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | KIO — Slide Stainer, Immersion Type |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.3800 |