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510(k) K813077

TECHNICON RA 1000 SYSTEM by Technicon Corp. — Product Code JJC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1981
Date Received
November 2, 1981
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

Other clearances by Technicon Corp.

  • K791323 — TECHNION ELECTRONIC FEVER THERMOMETER (September 7, 1979)

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  • K890332 — RFA/2 RAPID FLOW ANALYZER W/COMPUTER (February 17, 1989)
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  • K875105 — TECHNICON SMAC 3 SYSTEM (February 16, 1988)
  • K870998 — TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS (May 26, 1987)
  • K862561 — TECHNICON RA-XT SYSTEM WITH ANALYTES (October 20, 1986)