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510(k) K870998

TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS by Technicon Instruments Corp. — Product Code JJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1987
Date Received
March 11, 1987
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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  • K875105 — TECHNICON SMAC 3 SYSTEM (February 16, 1988)
  • K862561 — TECHNICON RA-XT SYSTEM WITH ANALYTES (October 20, 1986)
  • K854345 — TECHNICON RA-500 SYSTEM (November 26, 1985)