K132462 is an FDA 510(k) clearance for the S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE. This device is classified as a Urease, Photometric, Urea Nitrogen (Class II - Special Controls, product code CDN).
Submitted by Hitachi Chemical Diagnostics, Inc. (Los Angeles, US). The FDA issued a Cleared decision on October 28, 2013, 82 days after receiving the submission on August 7, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1770.
| 510(k) Number | K132462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2013 |
| Decision Date | October 28, 2013 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CDN - Urease, Photometric, Urea Nitrogen |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1770 |