510(k) K993941
- Device
- UBAS
- Applicant
- MARUKIN DIAGNOSTICS
- 510(k) number
- K993941
- Product code
- KWX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-03-02
- Date received
- 1999-11-19
- 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
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 |
|---|---|---|---|
| K980525 | UBAS MANUAL METHOD AND UBAS AUTOMATED METHOD | Marukin Shoyu Co., Ltd. | 1998-04-15 |
Legacy Summary#
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FDA Review#
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