510(k) K984402
K984402 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT". The FDA issued a decision of Substantially Equivalent on January 29, 1999. The device falls under product code JIF (Enzymatic Method, Ammonia), a Class I device regulated under 21 CFR 862.1065. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1999
- Date Received
- December 9, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzymatic Method, Ammonia
- Device Class
- Class I
- Regulation Number
- 862.1065
- Review Panel
- CH
- Submission Type