WAKO(TM) ZN TEST

K Number: K863920 · Decision Sep 16, 1987

Classifications

FEI Numbers

Registration Numbers

Same Product Code

Applicant Total

124

Review Days

343

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

K Number	Device Name	Decision Date	Decision
K100464	UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION	Feb 23, 2011	Substantially Equivalent
K080125	APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201	Jul 18, 2008	Substantially Equivalent
K080123	APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201	Jul 17, 2008	Substantially Equivalent
K061775	WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR	Feb 23, 2007	Substantially Equivalent
K062368	WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401	Jan 31, 2007	Substantially Equivalent
K053132	WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791	Dec 30, 2005	Substantially Equivalent
K053131	WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191	Dec 30, 2005	Substantially Equivalent
DEN050002	LBA AFP-L3, AFP-L3 CALIBRATOR SET, AFP-L3 CONTROL SET AND LIBASYS	May 19, 2005	Unknown
K042551	MULTI-CHEM CALIBRATOR A	Nov 16, 2004	Substantially Equivalent
K042550	MULTI-LIPID CALIBRATOR	Nov 8, 2004	Substantially Equivalent

This FDA 510(k) entry is associated with 0 FEI numbers. Click on an entry to view related FDA registrations.

This FDA 510(k) entry is associated with 0 registration numbers. Click on an entry to view related FDA registrations.

FDA 510(k) Clearances

Search all FDA 510(k) premarket notifications in our database.

Applicant

Wako Chemicals USA, Inc.

510(k) Predicate Finder

Find potential predicate devices related to this 510(k).