510(k) K901141
K901141 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX". The FDA issued a decision of Substantially Equivalent on April 9, 1990. The device falls under product code JJC (Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use), a Class I device regulated under 21 CFR 862.2150. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 1990
- Date Received
- March 13, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2150
- Review Panel
- CH
- Submission Type