510(k) K041643
K041643 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT". The FDA issued a decision of Substantially Equivalent on August 18, 2004. The device falls under product code CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus), a Class I device regulated under 21 CFR 862.1580. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2004
- Date Received
- June 17, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Phosphomolybdate (Colorimetric), Inorganic Phosphorus
- Device Class
- Class I
- Regulation Number
- 862.1580
- Review Panel
- CH
- Submission Type