510(k) K913911
K913911 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET". The FDA issued a decision of Substantially Equivalent on November 1, 1991. The device falls under product code DPJ (Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.), a Class II device regulated under 21 CFR 862.3100. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 1991
- Date Received
- August 30, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.
- Device Class
- Class II
- Regulation Number
- 862.3100
- Review Panel
- TX
- Submission Type