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510(k) K912616

TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES by Technicon Instruments Corp. — Product Code KLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1991
Date Received
June 13, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Device Class
Class II
Regulation Number
862.1700
Review Panel
CH
Submission Type

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  • K903305 — TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD (September 27, 1990)
  • K903306 — TECHNICON CHEM I SYSTEM MAGNESIUM METHOD (August 29, 1990)
  • K901410 — TECHNICON RA-2000(TM) SYSTEM (July 17, 1990)
  • K902243 — TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES (July 5, 1990)

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