Data / Medical devices / Japan / FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki)

FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki): FDA-registered device maker in Amagasaki-shi Hyogo, Japan, 10 510(k) clearances

Name: FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki) FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

FUJIFILM Wako Pure Chemical Corporation Diagnostics Design Office (Amagasaki) is registered with the FDA (registration 3003419906) in Amagasaki-shi Hyogo, Japan. It lists 12 device types. The FDA files 10 510(k) clearances under its listings, the newest dated February 23, 2011. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003419906
Address: 6-1 Takata-cho, Amagasaki-shi Hyogo, Japan, 661-0963
Owner or operator: FUJIFILM Wako Pure Chemical Corporation (8030234)
Roles: Specification developer
First device listed: January 25, 2006
Registered through: 2026
Brand names listed: AUTOKIT CH50, Alinity c Microalbumin Calibrators, Alinity c Microalbumin Controls, Alinity c Microalbumin Reagent Kit, Autokit Micro Albumin, Autokit Micro Albumin Calibrator Set, Autokit Micro Albumin Control Set, CH50 Calibrator and more

Devices it lists

Device	Product code	Class	Role	Source
Calibrator, Multi-Analyte Mixture	JIX	2	Specification developer	accessdata.fda.gov
Calibrator, Primary	JIS	2	Specification developer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Specification developer	accessdata.fda.gov
Complement C9, Antigen, Antiserum, Control	DAE	2	Specification developer	accessdata.fda.gov
Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma	OAU	2	Specification developer	accessdata.fda.gov
Ldl & Vldl Precipitation, Hdl	LBR	1	Specification developer	accessdata.fda.gov
Micro Total Analysis Instrument System	OUE	2	Specification developer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Specification developer	accessdata.fda.gov
System, Test, Low Density, Lipoprotein	MRR	1	Specification developer	accessdata.fda.gov
Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment	NSF	2	Specification developer	accessdata.fda.gov
Titrimetric, Fatty Acids	JLH	1	Specification developer	accessdata.fda.gov
Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)	JIQ	1	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 23, 2011	K100464	UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION	NSF	Substantially Equivalent	Wako Chemicals USA, Inc.	accessdata.fda.gov
November 8, 2004	K042550	MULTI-LIPID CALIBRATOR	JIX	Substantially Equivalent	Wako Chemicals USA, Inc.	accessdata.fda.gov
April 11, 2003	K030320	WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET	JIS	Substantially Equivalent	Wako Chemicals USA, Inc.	accessdata.fda.gov
February 11, 2003	K030065	WAKO NEFA LINEARITY SET	JJX	Substantially Equivalent	Wako Chemicals USA, Inc.	accessdata.fda.gov
June 1, 2000	K001005	WAKO HDL-C/LDL-C CALIBRATOR	JIS	Substantially Equivalent	Wako Chemicals USA, Inc.	accessdata.fda.gov
September 22, 1998	K982271	WAKO DIRECT LDL-C	MRR	Substantially Equivalent	Wako Chemicals USA, Inc.	accessdata.fda.gov
December 24, 1996	K963847	WAKO DIRECT HDL-C	JIS	Substantially Equivalent	Wako Chemicals USA, Inc.	accessdata.fda.gov
June 14, 1996	K960874	COMPLEMENT CONTROL	JJX	Substantially Equivalent	Wako Chemicals USA, Inc.	accessdata.fda.gov
December 18, 1995	K954145	WAKO AUTOKIT CH50	DAE	Substantially Equivalent	Wako Chemicals USA, Inc.	accessdata.fda.gov
May 26, 1987	K871763	NEFA STANDARD SOLUTION CALIBRATOR	JIT	Substantially Equivalent	Wako Chemicals USA, Inc.	accessdata.fda.gov

Compare with other makers

Updated February 23, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.