Atlas FDA

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

LIZ — Predicate Candidate Screening

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

187 daysmedian FDA review time
243 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K914847CD8 MONOCLONAL ANTIBODIESGen Trak, Inc.1992-06-192350
K860830TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHODTechnicon Instruments Corp.1986-09-081870
K843062TBM-REAGENT FOR T,B CELL & MONOCYTESBd Becton Dickinson Vacutainer Systems Preanalytic1985-04-032430
K842218ANTI-LEU-4 FITC LYSIN C BUFFERBd Becton Dickinson Vacutainer Systems Preanalytic1984-12-272060
K833929WHITE BLOOD CELLS HUMAN TAND BControl Diagnostics1984-02-031080
K831053QUANTIGEN T & B CELL ASSAYBio-Rad1983-08-081290
K820643ORTHO SPECTRUM III & ORTHO-MUNE OKOrtho Diagnostic Systems, Inc.1982-07-141280

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