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

Pcl-Ria, Inc. — Predicate Candidate Screening

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

34 daysmedian FDA review time

71 days90th percentile

29clearances measured

K-number	Device	Applicant	Decided	Review days
K830526	B-GCG SYSTEM BY RIA	Pcl-Ria, Inc.	1983-04-05	47
K823014	DIGOXIN KIT	Pcl-Ria, Inc.	1982-11-01	19
K822935	THYROID STIMULATING HORMONE	Pcl-Ria, Inc.	1982-11-01	28
K822612	T3 UPTAKE KITS	Pcl-Ria, Inc.	1982-09-30	31
K820886	THYROXINE T4 KIT	Pcl-Ria, Inc.	1982-04-16	17
K820358	FOLLICLE STIMULATING HORMONE KIT	Pcl-Ria, Inc.	1982-03-26	45
K820357	LUTEINIZING HORMONE KIT	Pcl-Ria, Inc.	1982-03-25	44
K812666	THYROXINE (T4) 125I	Pcl-Ria, Inc.	1981-10-02	11
K810867	FOLLICLE STIMULATING HORMONE (FSH)	Pcl-Ria, Inc.	1981-04-14	14
K810852	FOLLICLE STIMULATING HORMONE ANTISERUM	Pcl-Ria, Inc.	1981-04-08	9
K810754	LUTENIZING HORMONES	Pcl-Ria, Inc.	1981-03-31	11
K810741	LUTEINIZING HORMONE	Pcl-Ria, Inc.	1981-03-31	12
K803180	1-125 LABELED TRIIODOTHYRONINE(T3)	Pcl-Ria, Inc.	1981-01-09	24
K803047	I-125 LABELED DIGOXIN	Pcl-Ria, Inc.	1980-12-22	21
K790864	RABBIT ANTISERUM TO HUMAN CHORIONIC	Pcl-Ria, Inc.	1979-07-17	71
K790863	HUMAN CHORIONIC GONADOTROPHIN STANDARDS	Pcl-Ria, Inc.	1979-07-17	71
K790876	LABELED HUMAN CHORIONIC GONADOTROPHIN	Pcl-Ria, Inc.	1979-07-17	71
K781284	RABBIT ANTIBODY TO HUMAN T3	Pcl-Ria, Inc.	1978-08-31	36
K781069	T3 STANDARDS IN HUMAN SERUM	Pcl-Ria, Inc.	1978-08-14	49
K781071	STANDARDS, HORMONE, THYROID STIMULATING	Pcl-Ria, Inc.	1978-08-14	49
K780889	DIGOXIN STANDARDS IN HUMAN SERUM	Pcl-Ria, Inc.	1978-08-14	75
K781070	SECOND ANTIBODY	Pcl-Ria, Inc.	1978-08-10	45
K780576	125-I LABELED HUMAN LUTEINIZING HORMONE	Pcl-Ria, Inc.	1978-05-19	39
K780316	RABBIT ANTIBODY TO DIGOXIN	Pcl-Ria, Inc.	1978-03-17	21
K780059	RABBIT ANTIBODY/THYROID STIMUL. HORMONE	Pcl-Ria, Inc.	1978-02-13	34
K780050	THYROXINE STDS. IN HUMAN SERUM	Pcl-Ria, Inc.	1978-02-13	35
K780015	THYROID STIMULATING HORMONE	Pcl-Ria, Inc.	1978-02-07	35
K780016	HUMAN FOLLICLE STIMULATING HORMONE	Pcl-Ria, Inc.	1978-02-03	31
K772096	IN VITRO DIAGNOSTIC REAGENT	Pcl-Ria, Inc.	1977-11-22	15

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