K010670 is an FDA 510(k) clearance for the PICCOLO CHLORIDE TEST SYSTEM. This device is classified as a Mercuric Thiocyanate, Colorimetry, Chloride (Class II - Special Controls, product code CHJ).
Submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on April 26, 2001, 51 days after receiving the submission on March 6, 2001.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1170.
| 510(k) Number | K010670 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2001 |
| Decision Date | April 26, 2001 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CHJ — Mercuric Thiocyanate, Colorimetry, Chloride |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1170 |