K082329 is an FDA 510(k) clearance for the VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE. This device is classified as a Reagent, Borrelia Serological Reagent (Class II - Special Controls, product code LSR).
Submitted by Viramed Biotech AG (Oceanside, US). The FDA issued a Cleared decision on August 5, 2009, 356 days after receiving the submission on August 14, 2008.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K082329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2008 |
| Decision Date | August 05, 2009 |
| Days to Decision | 356 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LSR - Reagent, Borrelia Serological Reagent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3830 |