Submission Details
| 510(k) Number | K860662 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 24, 1986 |
| Decision Date | March 14, 1986 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
K860662 is an FDA 510(k) clearance for the AMRESCO FLOW PAC CHLORIDE REAGENT NO. 2256 & 2271, a Mercuric Thiocyanate, Colorimetry, Chloride (Class II — Special Controls, product code CHJ), submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on March 14, 1986, 18 days after receiving the submission on February 24, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1170.
| 510(k) Number | K860662 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 24, 1986 |
| Decision Date | March 14, 1986 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CHJ — Mercuric Thiocyanate, Colorimetry, Chloride |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1170 |