K870214 is an FDA 510(k) clearance for the MODIFIED SALTEX REAGENT STRIPS. This device is classified as a Mercuric Nitrate And Diphenyl Carbazone (titrimetric), Chloride (Class II - Special Controls, product code CHK).
Submitted by Miles Laboratories, Inc. (Elkhart, US). The FDA issued a Cleared decision on June 29, 1987, 160 days after receiving the submission on January 20, 1987.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1170.
| 510(k) Number | K870214 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 1987 |
| Decision Date | June 29, 1987 |
| Days to Decision | 160 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CHK — Mercuric Nitrate And Diphenyl Carbazone (titrimetric), Chloride |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1170 |