510(k) K080183
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 by
Roche Diagnostics Corp.
— Product Code DIF
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 2008
- Date Received
- January 25, 2008
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Drug Mixture Control Materials
- Device Class
- Class I
- Regulation Number
- 862.3280
- Review Panel
- TX
- Submission Type