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510(k) K903305

TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD by Technicon Instruments Corp. — Product Code KHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1990
Date Received
July 24, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzymatic, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

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  • K901410 — TECHNICON RA-2000(TM) SYSTEM (July 17, 1990)
  • K902243 — TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES (July 5, 1990)

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