The following data is part of a premarket notification filed by Viramed Biotech Ag with the FDA for Viramed Biotech Borrelia B31 Igg Virablot.
| Device ID | K051071 |
| 510k Number | K051071 |
| Device Name: | VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | VIRAMED BIOTECH AG 1730 SOUTH DITMAR STREET Oceanside, CA 92054 |
| Contact | Barry E Menefee |
| Correspondent | Barry E 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 | 2005-04-26 |
| Decision Date | 2005-08-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EVIRBBBGUS1 | K051071 | 000 |