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510(k) K964053

HEMOCUE GLUCOTROL by Direct Solutions — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1996
Date Received
September 30, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Direct Solutions

  • K963909 — HEMOCUE GLUCOLIN (November 8, 1996)
  • K964052 — HEMOCUE HEMOTROL (November 6, 1996)
  • K963908 — HEMOCUE HEMOLIN (October 16, 1996)
  • K955340 — EUROTROL GAS - ISE CONTROL (December 26, 1995)

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