510(k) K141173
K141173 is an FDA 510(k) premarket notification submitted by Quidel Corporation for the device "AMPLIVUE GAS ASSAY". The FDA issued a decision of Substantially Equivalent on July 24, 2014. The device falls under product code PGX (Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System), a Class II device regulated under 21 CFR 866.2680. Quidel Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2014
- Date Received
- May 6, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
- Device Class
- Class II
- Regulation Number
- 866.2680
- Review Panel
- MI
- Submission Type
An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.