K883049 is an FDA 510(k) clearance for the ATS PARA-SET IODINE ALCOHOL SOLUTION. This device is classified as a Stains, Microbiologic (Class I - General Controls, product code JTS).
Submitted by Alpha-Tec Systems, Inc. (Irvine, US). The FDA issued a Cleared decision on August 17, 1988, 29 days after receiving the submission on July 19, 1988.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K883049 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1988 |
| Decision Date | August 17, 1988 |
| Days to Decision | 29 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 |