510(k) K052645
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; by
Ortho-Clinical Diagnostics
— Product Code GTQ
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2005
- Date Received
- September 26, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antistreptolysin - Titer/Streptolysin O Reagent
- Device Class
- Class I
- Regulation Number
- 866.3720
- Review Panel
- MI
- Submission Type