K911613 is an FDA 510(k) clearance for the VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4. This device is classified as a Fluorescent Immunoassay, Tobramycin (Class II - Special Controls, product code LCR).
Submitted by Exmoor Plastics , Ltd. (Taunton, GB). The FDA issued a Cleared decision on June 28, 1991, 86 days after receiving the submission on April 3, 1991.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3900.
| 510(k) Number | K911613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1991 |
| Decision Date | June 28, 1991 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | LCR — Fluorescent Immunoassay, Tobramycin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3900 |