510(k) K935667
K935667 is an FDA 510(k) premarket notification submitted by Becton Dickinson Advanced Diagnostics for the device "QTEST(R) STREP". The FDA issued a decision of Substantially Equivalent on April 21, 1994. The device falls under product code GTY (Antigens, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Becton Dickinson Advanced Diagnostics has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1994
- Date Received
- November 26, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigens, All Groups, Streptococcus Spp.
- Device Class
- Class I
- Regulation Number
- 866.3740
- Review Panel
- MI
- Submission Type