510(k) K901141

PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX by Baxter Healthcare Corp — Product Code JJC

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