K861893 is an FDA 510(k) clearance for the GGT REAGENT CARTRIDGE (PRODUCT NO. 88204). This device is classified as a Block, Bite (Class II - Special Controls, product code JXL).
Submitted by Hi Chem, Inc. (Brea, US). The FDA issued a Cleared decision on June 5, 1986, 20 days after receiving the submission on May 16, 1986.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 882.5070.
| 510(k) Number | K861893 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 1986 |
| Decision Date | June 05, 1986 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JXL — Block, Bite |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5070 |