Company ยท US
Viramed Biotech AG
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2022. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 19, 2022 | K220016 | Viramed Borrela All-In-One ViraChip Test Kit Viramed Biotech AG, DE | LSR |
| Aug 22, 2017 | K163695 | Borrelia B31 ViraChip IgM Test Kit Viramed Biotech AG, DE | LSR |
| Jul 12, 2017 | K163504 | Borrelia B31 ViraChip IgG Test Kit Viramed Biotech AG, DE | LSR |
| Nov 25, 2009 | K092693 | VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS Viramed Biotech AG | LSR |
| Aug 5, 2009 | K082329 | VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE Viramed Biotech AG | LSR |
| Aug 11, 2005 | K051169 | BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT Viramed Biotech AG | LSR |
| Aug 11, 2005 | K051071 | VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT Viramed Biotech AG | LSR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||