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510(k) K901141

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

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

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  • K881056 — AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 (November 15, 1988)
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  • K870998 — TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS (May 26, 1987)
  • K862561 — TECHNICON RA-XT SYSTEM WITH ANALYTES (October 20, 1986)
  • K854345 — TECHNICON RA-500 SYSTEM (November 26, 1985)