510(k) K073078
K073078 is an FDA 510(k) premarket notification submitted by American Bio Medica Corp. for the device "RAPID TOX CUP". The FDA issued a decision of Substantially Equivalent on May 30, 2008. The device falls under product code LAG (High Pressure Liquid Chromatography, Methamphetamine), a Class II device regulated under 21 CFR 862.3610. American Bio Medica Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 2008
- Date Received
- October 31, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- High Pressure Liquid Chromatography, Methamphetamine
- Device Class
- Class II
- Regulation Number
- 862.3610
- Review Panel
- TX
- Submission Type