HOLOTC RIA— 510(k) K030655
Substantially EquivalentAxis-Shield Biochemicals, Asa
FDA 510(k) clearance K030655 for HOLOTC RIA, Substantially Equivalent on 2004-01-29. Applicant: Axis-Shield Biochemicals, Asa. Device class: 2.
Clearance details
- Applicant
- Axis-Shield Biochemicals, Asa
- Product code
- Code CDD
- Device class
- Class 2
- Regulation
- 21 CFR 862.1810
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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More clearances from Axis-Shield Biochemicals, Asa
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