Data / Medical devices / United States / FUJIFILM Healthcare Americas Corporation
FUJIFILM Healthcare Americas Corporation: FDA-registered device maker in Edison, NJ, United States, 10 510(k) clearances
FUJIFILM Healthcare Americas Corporation is registered with the FDA (registration 3005625991) in Edison, NJ, United States. It lists 12 device types. The FDA files 10 510(k) clearances under its listings, the newest dated February 23, 2011. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005625991
- Address
- 1100 King Georges Post Rd, Edison, NJ, United States, 08837
- Owner or operator
- FUJIFILM CORPORATION (8031568)
- Roles
- Repackager or relabeler
- First device listed
- January 31, 2014
- 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
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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 30, 2013 | 65084 | Class II | Terminated | uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Moun | Product fails to meet the accuracy at the low end of the measuring range. | accessdata.fda.gov |
| January 30, 2012 | 61084 | Not yet classified | Terminated | Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo-Ku Osaka, Japan***D | In-vitro diagnostic kit calibrator is defective and could impact patient profile for cardiovascular disease. | accessdata.fda.gov |
| March 30, 2007 | 37921 | Not yet classified | Terminated | NEFA Standard Solution Calibrator, Oleic Acid, 1 mmol/L, 4x10mL bottles per carton, Cat. 276-76491, labeled in part ***For in vitro diagnostic use ***Distributed by: Wako Chemicals, USA, Inc. 1600 Bellwood Road Richmond, | Diagnostic reagent for clinical laboratory testing was incorrectly labeled. | accessdata.fda.gov |
| July 6, 2006 | 35885 | Not yet classified | Terminated | Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box,Waco Chemicals USA, Inc., 1600 Bellwood Road Richmond, VA 23237, Manufactured by: Wako Pure Chemical Industries, Ltd. Osaka Japan | Unexpected low cholesterol results-The Cholesterol calibrator (Lp(a)) component of the in vitro diagnostic kit for cholesterol testing, has provided patient results lower than the correct value. | accessdata.fda.gov |
Compare with other makers
- All makers of Calibrator, Primary
- All makers of Ldl & Vldl Precipitation, Hdl
- All makers of System, Test, Low Density, Lipoprotein
- All makers of Titrimetric, Fatty Acids
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Updated July 30, 2013. 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.