MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT— 510(k) K060896
Substantially EquivalentVarian, Inc.
FDA 510(k) clearance K060896 for MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT, Substantially Equivalent on 2006-06-09. Applicant: Varian, Inc.. Device class: 2.
Clearance details
- Applicant
- Varian, Inc.
- Product code
- Code DJC
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Forest, CA, US
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More clearances from Varian, Inc.
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