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

Wiener Laboratories Saic — Predicate Candidate Screening

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

60 daysmedian FDA review time

137 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days
K023889	WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TES	Wiener Laboratories Saic	2004-02-11	447
K024305	WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006	Wiener Laboratories Saic	2003-03-18	84
K024116	WIENER LAB. BILIRUBINA DIRECT AA	Wiener Laboratories Saic	2003-02-12	61
K023992	WIENER LAB COLINESTERASA AA	Wiener Laboratories Saic	2003-02-12	72
K023744	WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR.	Wiener Laboratories Saic	2003-01-03	57
K023551	WIENER LAB GOT (AST) UV AA LIQUIDA	Wiener Laboratories Saic	2002-12-09	48
K023549	WIENER LAB AMILASA 405 AA LIQUIDA	Wiener Laboratories Saic	2002-12-09	48
K023550	WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA	Wiener Laboratories Saic	2002-12-09	48
K022962	WIENER LAB. BILIRRUBINA TOTAL AA	Wiener Laboratories Saic	2002-11-01	56
K021334	WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR.	Wiener Laboratories Saic	2002-09-10	137
K021332	WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIE	Wiener Laboratories Saic	2002-07-03	68
K013983	WIENER LAB. ALP 405	Wiener Laboratories Saic	2002-01-28	56
K013652	WIENER LAB. CA-COLOR AA, MODEL 4 X 50 ML CAT.N 1152002	Wiener Laboratories Saic	2001-12-21	45
K011953	WIENER LAB. GLICEMIA ENZIMATICA AA MODELS 1 X 250 ML CAT. #1	Wiener Laboratories Saic	2001-12-21	183
K013145	WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITES	Wiener Laboratories Saic	2001-11-27	68
K013101	WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405	Wiener Laboratories Saic	2001-11-16	60
K013095	WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X2	Wiener Laboratories Saic	2001-11-16	60
K013102	WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR	Wiener Laboratories Saic	2001-11-13	57
K013097	WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003	Wiener Laboratories Saic	2001-11-13	57
K012326	WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001	Wiener Laboratories Saic	2001-11-08	108
K012065	WIENER LAB. CREATININA CINETICA AA	Wiener Laboratories Saic	2001-10-10	100
K012329	WIENER LAB.ALBUMINA AA, MODELS 6X60 ML CAT N 1690008, 6X120	Wiener Laboratories Saic	2001-09-21	60
K012260	WIENER LAB. UREA UV CINETICA AA	Wiener Laboratories Saic	2001-09-19	63
K010421	WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGU	Wiener Laboratories Saic	2001-04-13	60

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