K840210 is an FDA 510(k) clearance for the REPTILASE-R HA35. This device is classified as a Bothrops Atrox Reagent (Class II - Special Controls, product code JCO).
Submitted by Wellcome Diagnostics (Mchenry, US). The FDA issued a Cleared decision on April 23, 1984, 95 days after receiving the submission on January 19, 1984.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8100.
| 510(k) Number | K840210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 1984 |
| Decision Date | April 23, 1984 |
| Days to Decision | 95 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JCO — Bothrops Atrox Reagent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8100 |