Atlas FDA

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

NBT — Predicate Candidate Screening

8 FDA 510(k) clearances under this product code; the 50 most recent screened below.

188 daysmedian FDA review time
441 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K071711ASCA-CHEKTechlab Inc., Corporate Research Center2007-11-071380
K051927TECHLAB ASCA-CHEKTechlab, Inc.2006-04-062620
K051492AESKULISA ASCA AAesku, Inc.2005-11-141610
K042579BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KITThe Binding Site2005-07-283090
K032860IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)Immco Diagnostics, Inc.2004-03-181880
K032850IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG)Immco Diagnostics, Inc.2004-03-181880
K000733QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISAInova Diagnostics, Inc.2001-05-214410
DEN000007QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISAInova Diagnostics, Inc.2000-08-16290

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