Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Viramed Biotech AG · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

210 daysmedian FDA review time
356 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K220016Viramed Borrela All-In-One ViraChip Test KitViramed Biotech AG2022-08-192260
K163695Borrelia B31 ViraChip IgM Test KitViramed Biotech AG2017-08-222370
K163504Borrelia B31 ViraChip IgG Test KitViramed Biotech AG2017-07-122100
K092693VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGViramed Biotech AG2009-11-25840
K082329VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPEViramed Biotech AG2009-08-053560
K051071VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOTViramed Biotech AG2005-08-111070
K051169BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOTViramed Biotech AG2005-08-111040

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda