Data / Medical devices / Japan / Nittobo Medical Co., Ltd. Medical Development Center
Nittobo Medical Co., Ltd. Medical Development Center: FDA-registered device maker in Koriyama Fukushima, Japan, 12 510(k) clearances
Nittobo Medical Co., Ltd. Medical Development Center is registered with the FDA (registration 1000403749) in Koriyama Fukushima, Japan. It lists 30 device types. The FDA files 12 510(k) clearances under its listings, the newest dated March 19, 2008. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1000403749
- Address
- 1, Shiojima, Fukuhara Fukuyama, Koriyama Fukushima, Japan, 963-8061
- Owner or operator
- Nittobo Medical Co., Ltd. (9028746)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 2, 1997
- Registered through
- 2027
- Brand names listed
- K-ASSAY Apo AI, K-ASSAY Apo B, K-ASSAY CRP (Ver.2), K-ASSAY CRP Calibrator, K-ASSAY Fibrinogen, N-ASSAY TIA Apo AI
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 |
|---|---|---|---|---|---|---|
| March 19, 2008 | K071525 | ACTIVATED ASPARTATE AMINOTRANSFERASE | CIT | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 24, 1999 | K993480 | K-ASSAY HAPTOGLOBIN | DAD | Substantially Equivalent | Kamiya Biomedical Co. | accessdata.fda.gov |
| February 16, 1999 | K983070 | CK | CGS | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| January 29, 1999 | K983289 | APOLIPOPROTEIN A1 | DER | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| January 26, 1999 | K983281 | APOB | DFC | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983441 | C3 | CZW | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983359 | IGA | CZP | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983356 | C4 | DBI | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983221 | IGG | DEW | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983167 | TRF | DDG | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983132 | IGM | DFT | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| September 28, 1998 | K983131 | AST | CIT | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
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Updated March 19, 2008. 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.