The following data is part of a premarket notification filed by Viramed Biotech Ag with the FDA for Viramed Biotech Ag Borrelia B31 Igg Virastripe, Model V-bbsgus.
| Device ID | K092693 |
| 510k Number | K092693 |
| Device Name: | VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | VIRAMED BIOTECH AG 1730 SOUTH DITMAR STREET Oceanside, CA 92054 |
| Contact | Barry Menefee |
| Correspondent | Barry Menefee VIRAMED BIOTECH AG 1730 SOUTH DITMAR STREET Oceanside, CA 92054 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-02 |
| Decision Date | 2009-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EVIRBBSGUS1 | K092693 | 000 |
| EVIRBBSGPS1 | K092693 | 000 |
| EVIRBBSGDS1 | K092693 | 000 |