K810229 is an FDA 510(k) clearance for the SCEPTOR SYSTEM AUTOMATED MODEL 216. This device is classified as a Device, Microtiter Diluting/dispensing (Class I - General Controls, product code JTC).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Walker, US). The FDA issued a Cleared decision on February 9, 1981, 13 days after receiving the submission on January 27, 1981.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2500.
| 510(k) Number | K810229 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 1981 |
| Decision Date | February 09, 1981 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTC — Device, Microtiter Diluting/dispensing |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2500 |