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510(k) K926015

CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3 by Cala Diagnostics — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1992
Date Received
November 30, 1992
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 Cala Diagnostics

  • K944246 — CARDIOCHEX CKMB MASS MEASUREMENT CONTROL (October 31, 1994)
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  • K944243 — CARDIOCHEX (October 27, 1994)
  • K930874 — LD-1 CONTROL-LEVEL 1 & 2 (April 22, 1993)
  • K930873 — CKMB ISOENZYME CONTROL-LEVEL 1,2.3 (April 13, 1993)
  • K930875 — CKMB CONTROL - LEVEL 1,2,3 (April 13, 1993)
  • K915503 — FIBRINOGEN FDP CONTROL (January 30, 1992)
  • K912827 — SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 (August 12, 1991)
  • K912826 — WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 (July 26, 1991)
  • K864456 — CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3 (May 6, 1987)

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