Atlas FDA

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

Techlab Inc., Corporate Research Center · Predicate Candidate Screening

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

148 daysmedian FDA review time
245 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K121411SHIGA TOXIN CHEKTechlab Inc., Corporate Research Center2012-10-021440
K121364SHIGA TOXIN QUIK CHEKTechlab Inc., Corporate Research Center2012-10-021480
K103673GIARDIA/ CRYPTOSPORIDIUM QUIK CHEKTechlab Inc., Corporate Research Center2011-08-182450
K071712LEUKO EZ VUETechlab Inc., Corporate Research Center2007-12-041650
K071711ASCA-CHEKTechlab Inc., Corporate Research Center2007-11-071380

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