510(k) K983268
K983268 is an FDA 510(k) premarket notification submitted by Diagnostic Reagents, Inc. for the device "MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY". The FDA issued a decision of Substantially Equivalent on November 18, 1998. The device falls under product code LFH (U.V. Spectrometry, Tricyclic Antidepressant Drugs), a Class II device regulated under 21 CFR 862.3910. Diagnostic Reagents, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 1998
- Date Received
- September 17, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- U.V. Spectrometry, Tricyclic Antidepressant Drugs
- Device Class
- Class II
- Regulation Number
- 862.3910
- Review Panel
- TX
- Submission Type