AXIS %CDT TURBIDIMETRIC IMMUNOASSAY— 510(k) K992502
Substantially EquivalentAxis
FDA 510(k) clearance K992502 for AXIS %CDT TURBIDIMETRIC IMMUNOASSAY, Substantially Equivalent on 1999-12-21. Applicant: Axis. Device class: 1.
Clearance details
- Applicant
- Axis
- Product code
- Code NAO
- Device class
- Class 1
- Regulation
- 21 CFR 862.1360
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code NAO
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