510(k) K021526
K021526 is an FDA 510(k) premarket notification submitted by ACON Laboratories, Inc. for the device "ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE". The FDA issued a decision of Substantially Equivalent on July 17, 2002. The device falls under product code LFG (Radioimmunoassay, Tricyclic Antidepressant Drugs), a Class II device regulated under 21 CFR 862.3910. ACON Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 2002
- Date Received
- May 10, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Tricyclic Antidepressant Drugs
- Device Class
- Class II
- Regulation Number
- 862.3910
- Review Panel
- TX
- Submission Type
Intended to measure any of the tricyclic antidepressant drugs in serum or urine.