K911356 is an FDA 510(k) clearance for the LEGIONELLA STAT IGG/IGM TEST KIT. This device is classified as a Legionella, Spp., Elisa (Class II - Special Controls, product code MJH).
Submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on July 30, 1992, 490 days after receiving the submission on March 28, 1991.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3300.
| 510(k) Number | K911356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1991 |
| Decision Date | July 30, 1992 |
| Days to Decision | 490 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | MJH — Legionella, Spp., Elisa |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3300 |