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

Endocrine-Metabolic Center — Predicate Candidate Screening

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

15 daysmedian FDA review time
125 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K821131RADIOIMMUNOASSAY PARATHYROID HORMONE MIDEndocrine-Metabolic Center1982-06-02430
K811993RADIOIMMUNOASSAY, FOLLICLE STIMULATINGEndocrine-Metabolic Center1981-08-03200
K811994RADIOIMMUNOASSAY LUTEINIZING HORMONEEndocrine-Metabolic Center1981-07-27130
K810948RADIOIMMUNOASSAY THYROID STIM. HORM. KITEndocrine-Metabolic Center1981-04-17100
K810351RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIEEndocrine-Metabolic Center1981-02-23130
K800188EMC-M-180, T3 UPTAKE - 100 TUBESEndocrine-Metabolic Center1980-02-13150
K800187EMC-M-175, THYROXINE - 100 TUBESEndocrine-Metabolic Center1980-02-13150
K790602RIA, DIGNXIN-125-IEndocrine-Metabolic Center1979-07-301250
K790630RIA, INSULIN, DOUBLE ANTIBODYEndocrine-Metabolic Center1979-07-241190

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