510(k) K983698
K983698 is an FDA 510(k) premarket notification submitted by Roche Diagnostic Systems, Inc. for the device "MODIFICATION TO ABUSCREEN ONLINE BARBITURATES". The FDA issued a decision of Substantially Equivalent on May 3, 1999. The device falls under product code DIS (Enzyme Immunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. Roche Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 1999
- Date Received
- October 21, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Barbiturate
- Device Class
- Class II
- Regulation Number
- 862.3150
- Review Panel
- TX
- Submission Type