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

Biotecx Laboratories, Inc. — Predicate Candidate Screening

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

51 daysmedian FDA review time

214 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days
K982298	OPTICOAT T4 EIA KIT	Biotecx Laboratories, Inc.	1999-02-03	217
K981824	OPTICOAT T3 EIA KIT	Biotecx Laboratories, Inc.	1998-12-22	214
K895407	CORTISOL CLASP-BEAD EIA KIT	Biotecx Laboratories, Inc.	1989-10-19	43
K893620	T3 CLASP-BEAD EIA KIT	Biotecx Laboratories, Inc.	1989-08-11	92
K892853	T4 CLASP-BEAD EIA KIT	Biotecx Laboratories, Inc.	1989-05-22	34
K883765	TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE	Biotecx Laboratories, Inc.	1988-10-31	55
K871211	PROGESTERONE CLASP RADIOIMMUNOASSAY KIT	Biotecx Laboratories, Inc.	1987-04-13	18
K863188	HPL RIA KIT	Biotecx Laboratories, Inc.	1986-09-25	37
K854876	ALDOSTERONE DIRECT RIA KIT	Biotecx Laboratories, Inc.	1986-03-17	101
K851540	ESTRADIOL DIRECT RIA KIT	Biotecx Laboratories, Inc.	1985-06-06	51
K844767	RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO	Biotecx Laboratories, Inc.	1985-02-01	56
K842957	CORITSOL PREMIX RIA KIT	Biotecx Laboratories, Inc.	1984-09-14	49
K842555	DHEA-S DIRECT RIA KIT	Biotecx Laboratories, Inc.	1984-08-07	36
K841333	PROGESTERONE DIRECT RIA KIT-RADIOIMM	Biotecx Laboratories, Inc.	1984-05-02	30
K780761	ELECTRO-PLETHYSMOGRAPH	Biotecx Laboratories, Inc.	1978-06-30	52

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