510(k) K060354
K060354 is an FDA 510(k) premarket notification submitted by Acro Biotech, LLC for the device "ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000". The FDA issued a decision of Substantially Equivalent on July 28, 2006. The device falls under product code JXM (Enzyme Immunoassay, Benzodiazepine), a Class II device regulated under 21 CFR 862.3170. Acro Biotech, LLC has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 28, 2006
- Date Received
- February 13, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Benzodiazepine
- Device Class
- Class II
- Regulation Number
- 862.3170
- Review Panel
- TX
- Submission Type