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

E-Y Laboratories, Inc. — Predicate Candidate Screening

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

228 daysmedian FDA review time
393 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K934130SWABZYME OXIDASEE-Y Laboratories, Inc.1994-09-143940
K940161B-LACTAMASE REAGENT TUBESE-Y Laboratories, Inc.1994-09-092400
K934125GONOCHEK-II, MODIFICATIONE-Y Laboratories, Inc.1994-09-093930
K940162GONOCHEK II REAGENT TUBESE-Y Laboratories, Inc.1994-09-092400
K940020STREP-A-CHEK(TM) REAGENT STRIPSE-Y Laboratories, Inc.1994-08-262350
K940124EY-20 REAGENT TUBESE-Y Laboratories, Inc.1994-08-262280
K934129STREP-A-CHEKE-Y Laboratories, Inc.1994-08-263790
K844276E-COLI-CHEK TUBEE-Y Laboratories, Inc.1984-12-13380
K842600STREP-A-CHEKE-Y Laboratories, Inc.1984-07-1180
K840810SWABZYME-OXIDASEE-Y Laboratories, Inc.1984-04-04610
K840884STREP-A-CHEK TUBEE-Y Laboratories, Inc.1984-03-23250
K833180GONOCHEK-IIE-Y Laboratories, Inc.1983-11-14560
K830756GONOCHEK PANELE-Y Laboratories, Inc.1983-08-121550

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