Inplex CF Molecular Test
FDA 510(k) K063787 · Third Wave Technologies, Inc.
Submission
- Device name
- Inplex CF Molecular Test
- Applicant
- Third Wave Technologies, Inc.
Madison, WI, US - Received
- December 21, 2006
- Decision date
- March 13, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUA – System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5900
- Specialty
- Immunology
The cftr gene mutation detection system is a device used to simultaneously detect and identify a panel of mutations and variants in the cftr gene. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (cf), carrier identification, and newborn screening. This device is not intended for stand-alone diagnostic purposes, prenatal diagnostic…
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| K060627 | Tag-It Cystic Fibrosis KitNUA · Special | Tm Bioscience Corporation | 06/07/2006SE |
| K060543 | Esensor Cystic Fibrosis Carrier Detection System, Model Esensor 4800NUA · Special | Clinical Micro Sensors, Inc. | 03/28/2006SE |
| K051435 | Esensor Cystic Fibrosis Carrier Detection Test , Esensor 4800 DNA Detection System…NUA · Traditional | Clinical Micro Sensors | 01/19/2006SE |
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Questions and answers
When was Inplex CF Molecular Test cleared by the FDA?
Inplex CF Molecular Test (K063787) received a 510(k) decision of Substantially Equivalent on March 13, 2008, 448 days after the submission was received.
What is the product code of K063787?
The FDA product code is NUA – System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection, a Class II (moderate risk) device regulated under 21 CFR 866.5900.