K911771 is an FDA 510(k) clearance for the ARD(TM) ANTIMICROBIAL REMOVAL DEVICE. This device is classified as a Antisera, If, Toxoplasma Gondii (Class II - Special Controls, product code LJK).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on July 1, 1991, 73 days after receiving the submission on April 19, 1991.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3780.
| 510(k) Number | K911771 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 1991 |
| Decision Date | July 01, 1991 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LJK — Antisera, If, Toxoplasma Gondii |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3780 |