510(k) K980525
- Device
- UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD
- Applicant
- MARUKIN SHOYU CO., LTD.
- 510(k) number
- K980525
- Product code
- KWX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-04-15
- Date received
- 1998-02-11
- Regulation
- 862.1187
- Classification name
- Radioimmunoassay, Conjugated Sulfalithocholic (slcg) Acid, Bile Acids
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- GREG HOLLAND
- Address
- 3722 Ave. Sausalito Irvine CA US 92606 92606
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KWX
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K993941 | UBAS | Marukin Diagnostics | 2000-03-02 |
Legacy Summary
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FDA Review
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