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

Radioimmunoassay, Inc. · Predicate Candidate Screening

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

28 daysmedian FDA review time
43 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K802135TESTOSTERONE RADIOIMMUNOASSY KITRadioimmunoassay, Inc.1980-10-10360
K800106LUTEINIZING HORMONE RADIOIMMUNOASSAY SYSRadioimmunoassay, Inc.1980-02-13280
K800107FOLLICLE STIMULATING HORMONERadioimmunoassay, Inc.1980-02-13280
K792539TRIIODOTHYRONINE RIA SYSTEMRadioimmunoassay, Inc.1980-01-16370
K792153DIGOXIN RADIOIMMUNOASSAY SYSTEMRadioimmunoassay, Inc.1979-11-13180
K792154THYROID STIMULATING HORMONERadioimmunoassay, Inc.1979-11-13190
K792036CORTISOL RADIOIMMUNOASSAY SYSTEMRadioimmunoassay, Inc.1979-10-30190
K780671125 I-T3 UPTAKE REAGENTRadioimmunoassay, Inc.1978-06-06430
K780672125 I-T4 RIA REAGENTRadioimmunoassay, Inc.1978-06-06430

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