510(k) K043556
K043556 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT". The FDA issued a decision of Substantially Equivalent on March 28, 2005. The device falls under product code JXM (Enzyme Immunoassay, Benzodiazepine), a Class II device regulated under 21 CFR 862.3170. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2005
- Date Received
- December 27, 2004
- 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