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

Stanbio Laboratory — Predicate Candidate Screening

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

60 daysmedian FDA review time

172 days90th percentile

47clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K090093	STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SY	Stanbio Laboratory	2009-06-10	147	0
K081719	STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTE	Stanbio Laboratory	2008-07-18	30	0
K050283	CREATININE LIQUICOLOR	Stanbio Laboratory	2005-06-30	143	0
K050266	DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR	Stanbio Laboratory	2005-06-30	146	0
K042169	STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER	Stanbio Laboratory	2005-03-14	215	0
K041155	WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY	Stanbio Laboratory	2004-10-14	164	0
K032936	DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/L	Stanbio Laboratory	2004-03-12	172	0
K032932	DIRECT HDL-CHOLESTEROL LIQUID COLOR; DIRECT HDL/LDL-CHOLESTE	Stanbio Laboratory	2004-03-10	170	0
K032482	STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTE	Stanbio Laboratory	2003-10-24	73	0
K020378	QUPID PLUS E.R.	Stanbio Laboratory	2002-06-21	136	0
K974429	RAPET CRP	Stanbio Laboratory	1998-02-18	86	0
K974370	RAPET RF	Stanbio Laboratory	1998-02-17	89	0
K972155	CREATINE KINASE (CK)	Stanbio Laboratory	1997-07-17	42	1
K962418	UREA NITROGEN (BUN) LIQUI-UV	Stanbio Laboratory	1996-12-26	185	0
K941314	STANBIO ALT/GPT (LUQUI-UV) TEST SET	Stanbio Laboratory	1994-07-20	124	0
K941315	STANBIO Y-GT (LIQUICOLOR) TEST SET	Stanbio Laboratory	1994-07-14	118	0
K941313	STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET	Stanbio Laboratory	1994-05-17	60	0
K932049	STANBIO AST/GOT (LIQUI-UV) TEST SET, CAT NO. 9020	Stanbio Laboratory	1993-11-16	203	0
K902204	STANBIO CSF/URINE TOTAL PROTEIN TEST SET	Stanbio Laboratory	1990-08-22	98	0
K893128	STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010	Stanbio Laboratory	1989-07-25	91	0
K883170	STANBIO MAGNESIUM TEST SET, CAT. NO 0130	Stanbio Laboratory	1989-02-07	195	0
K880144	STANBIO SYPHILIS RPR TEST, NO. 1170	Stanbio Laboratory	1988-05-23	131	0
K880467	STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR	Stanbio Laboratory	1988-03-24	50	0
K870746	STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715	Stanbio Laboratory	1987-06-01	96	0
K851278	ACETAZYME, STANBIO ACETAMINOPHEN PROC/TEST 0870	Stanbio Laboratory	1985-04-17	16	0
K842544	STANBIO QUICK-TELL MONOCLONAL INDIRECT	Stanbio Laboratory	1984-09-21	81	0
K832867	FERTITUBE PREGNANCY TEST #1120	Stanbio Laboratory	1984-02-03	163	0
K832640	QUICK-TELL INDIRECT PREGNANCY TEST	Stanbio Laboratory	1983-10-04	61	0
K832557	FERTITELL DIRECT PREGNANCY TEST #1100	Stanbio Laboratory	1983-09-12	42	0
K832444	ENZYMATIC TRIGLYCERIDES #2000	Stanbio Laboratory	1983-08-31	37	0
K832159	UNITIZED ENZYMATIC GLUCOSE TEST SET	Stanbio Laboratory	1983-08-16	42	0
K831858	TRIGLYCERIDES REAGENT SET	Stanbio Laboratory	1983-07-22	42	0
K831863	CHOLESTEROL-ENZYMATIC REAGENT SET	Stanbio Laboratory	1983-07-22	42	0
K831864	URIC-ACID TEST ENZYMATIC COLORIMETRIC	Stanbio Laboratory	1983-07-22	42	0
K823237	BARBITURATE TEST SET #0550-050	Stanbio Laboratory	1982-11-29	28	0
K813349	BI-LEVEL ACETAMINOPHEN-SALICYLATE CNRL	Stanbio Laboratory	1981-12-22	25	0
K810055	STANBIO BILIRUBIN TEST SET	Stanbio Laboratory	1981-02-02	20	0
K801014	STANBIO ACETAMINOPHEN TEST SET #0850	Stanbio Laboratory	1980-06-20	53	0
K800693	STANBIO PROSTATIC ACID PHOSPHATASE TEST	Stanbio Laboratory	1980-04-16	20	0
K800190	STANBIO DIRECT URIC ACID TEST SET #0770	Stanbio Laboratory	1980-02-13	15	0
K781865	IRON BINDING CAPICITY MODEL 0370	Stanbio Laboratory	1978-12-04	28	0
K781635	CHLORIDE TEST SET, CAT.# 0210	Stanbio Laboratory	1978-10-03	11	0
K780545	SR-PLUS DIRECT CHOLESTEROL TEST	Stanbio Laboratory	1978-05-26	53	0
K780110	CSF TOTAL PROTEIN TEST SET #0340	Stanbio Laboratory	1978-03-03	43	0
K772257	ALKALINE PHOSPHATASE TEST SET	Stanbio Laboratory	1977-12-22	17	0
K771856	DIR. QUANT. COLOR. DETERM. SERUM CREAT.	Stanbio Laboratory	1977-11-03	35	0
K771771	QUAN. COLOR. DETER. OF SERUM ALBUMIN	Stanbio Laboratory	1977-10-07	18	0

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