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

Ria Diagnostics — Predicate Candidate Screening

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

38 daysmedian FDA review time

133 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K855033	T-3 UPTAKE/RIASSAY	Ria Diagnostics	1986-01-24	38
K854798	T-4 RIASSAY	Ria Diagnostics	1986-01-15	44
K852537	T-3 RIASSAY	Ria Diagnostics	1985-08-12	59
K810296	DIGOXIN RIA ASSAY	Ria Diagnostics	1981-02-19	15
K801691	TSH RIASSAY	Ria Diagnostics	1980-08-27	35
K792062	THEOPHYLLINE RIASSAY	Ria Diagnostics	1980-02-25	133
K780012	ANTITHROMBIN III RIA	Ria Diagnostics	1978-01-20	17

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