Data / Medical devices / Japan / FUJIFILM Healthcare Manufacturing Corporation MIE Office
FUJIFILM Healthcare Manufacturing Corporation MIE Office: FDA-registered device maker in Komono-cho, Mie-gun, Japan, 10 510(k) clearances
FUJIFILM Healthcare Manufacturing Corporation MIE Office is registered with the FDA (registration 3003522182) in Komono-cho, Mie-gun, 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 3, 2026.
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- FDA registration number
- 3003522182
- Address
- 2613-2, Oaza Ogohara, Komono-cho, Mie-gun, Japan, 510-1222
- Owner or operator
- FUJIFILM Wako Pure Chemical Corporation (8030234)
- Roles
- Manufacturer
- 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 | Manufacturer | accessdata.fda.gov |
| Calibrator, Primary | JIS | 2 | Manufacturer | accessdata.fda.gov |
| Calibrator, Secondary | JIT | 2 | Manufacturer | accessdata.fda.gov |
| Complement C9, Antigen, Antiserum, Control | DAE | 2 | Manufacturer | accessdata.fda.gov |
| Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma | OAU | 2 | Manufacturer | accessdata.fda.gov |
| Ldl & Vldl Precipitation, Hdl | LBR | 1 | Manufacturer | accessdata.fda.gov |
| Micro Total Analysis Instrument System | OUE | 2 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| System, Test, Low Density, Lipoprotein | MRR | 1 | Manufacturer | accessdata.fda.gov |
| Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment | NSF | 2 | Manufacturer | accessdata.fda.gov |
| Titrimetric, Fatty Acids | JLH | 1 | Manufacturer | accessdata.fda.gov |
| Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | JIQ | 1 | Manufacturer | 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
- All makers of Calibrator, Primary
- All makers of Ldl & Vldl Precipitation, Hdl
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Titrimetric, Fatty Acids
- All makers of Calibrator, Multi-Analyte Mixture
- All makers of System, Test, Low Density, Lipoprotein
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.