510(k) K000494
K000494 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT". The FDA issued a decision of Substantially Equivalent on April 14, 2000. The device falls under product code LDP (Colorimetry, Acetaminophen), a Class II device regulated under 21 CFR 862.3030. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 2000
- Date Received
- February 15, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colorimetry, Acetaminophen
- Device Class
- Class II
- Regulation Number
- 862.3030
- Review Panel
- TX
- Submission Type