ACS 180 HOMOCYSTEINE ASSAY— 510(k) K013606
Substantially EquivalentBayer Diagnostics Corp.
FDA 510(k) clearance K013606 for ACS 180 HOMOCYSTEINE ASSAY, Substantially Equivalent on 2001-12-21. Applicant: Bayer Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Bayer Diagnostics Corp.
- Product code
- Code LPS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1377
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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More clearances from Bayer Diagnostics Corp.
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