BD Veritor(Tm) System for Rapid Detection of Group a Strep
FDA 510(k) K122718 · Becton, Dickinson and Company
510(k) numberK122718
Submission
- Device name
- BD Veritor(Tm) System for Rapid Detection of Group a Strep
- Applicant
- Becton, Dickinson and Company
San Diego, CA, US - Received
- September 5, 2012
- Decision date
- February 6, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GTY – Antigens, All Groups, Streptococcus Spp.
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Specialty
- Microbiology
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Questions and answers
When was BD Veritor(Tm) System for Rapid Detection of Group a Strep cleared by the FDA?
BD Veritor(Tm) System for Rapid Detection of Group a Strep (K122718) received a 510(k) decision of Substantially Equivalent on February 6, 2013, 154 days after the submission was received.
What is the product code of K122718?
The FDA product code is GTY – Antigens, All Groups, Streptococcus Spp., a Class I (low risk) device regulated under 21 CFR 866.3740.