INPLEX CF MOLECULAR TEST— 510(k) K063787
Substantially EquivalentThird Wave Technologies, Inc.
FDA 510(k) clearance K063787 for INPLEX CF MOLECULAR TEST, Substantially Equivalent on 2008-03-13. Applicant: Third Wave Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Third Wave Technologies, Inc.
- Product code
- Code NUA
- Device class
- Class 2
- Regulation
- 21 CFR 866.5900
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Madison, WI, US
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More clearances from Third Wave Technologies, Inc.
view allRecalls naming K063787
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063787.
Data sourced from openFDA. This site is unofficial and independent of the FDA.