510(k) K983704
K983704 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE". The FDA issued a decision of Substantially Equivalent on February 10, 1999. The device falls under product code JCM (Control, Hemoglobin, Abnormal), a Class II device regulated under 21 CFR 864.7415. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1999
- Date Received
- October 21, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Control, Hemoglobin, Abnormal
- Device Class
- Class II
- Regulation Number
- 864.7415
- Review Panel
- HE
- Submission Type