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510(k) K833804

SHABAN 9865 IL#78637 JUNCTION BLOC by Shaban Mfg. Co. — Product Code JJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1984
Date Received
November 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Chemistry, Micro, For Clinical Use
Device Class
Class I
Regulation Number
862.2170
Review Panel
CH
Submission Type

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  • K841609 — COMPONENTS FOR PARTIAL PRESSURE ELEE (May 25, 1984)
  • K840557 — REAGENTS & STANDARDS IL 501 NA/K (April 4, 1984)
  • K840468 — PARTIAL PRESS. ELECTRODE MEASUREMENT (March 30, 1984)

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