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510(k) K851151

FISHER DIAGNOSTICS KDA CALIBRATOR II by Fisher Scientific Co., LLC — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1985
Date Received
March 21, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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  • K871058 — SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) (April 6, 1987)
  • K863224 — HEMATALL-C PLUS HEMATOLOGY CONTROLS (October 29, 1986)
  • K862318 — FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR (July 10, 1986)

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