Atlas FDA

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

Ivd Research, Inc. — Predicate Candidate Screening

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

208 daysmedian FDA review time
275 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K081064GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LIvd Research, Inc.2009-01-142750
K032897C. DIFFICILE TOXIN A + B FECAL ANTIGEN DETECTION MICROWELL EIvd Research, Inc.2004-05-272530
K031059IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96Ivd Research, Inc.2003-07-101040
K024113IVD CRYPTO/GIARDIA DFAIvd Research, Inc.2003-03-05820
K020583IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96Ivd Research, Inc.2002-09-172080

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