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510(k) K913371

TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL by Creative Laboratory Products, Inc. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1991
Date Received
July 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Creative Laboratory Products, Inc.

  • K950589 — CLP HIGH LEVEL HIGH DENSITY LIPO PROTEIN CHOLESTEROL CONTROL-HL (March 20, 1995)
  • K942284 — CLP TOTAL IRON AND UIBC/TIBC LINEARITY CONTROL SET (August 26, 1994)
  • K922995 — LIPID CONTROLS (August 12, 1992)
  • K913427 — SICKLE HEMOGLOBIN (HBA/S) CONTROL SET (November 19, 1991)
  • K913585 — LIPASE LINEARITY CONTROL (October 21, 1991)
  • K913224 — LIPID LINEARITY CONTROLS (September 25, 1991)
  • K913496 — CHOLINESTERASE LINEARITY CONTROL (September 11, 1991)
  • K912823 — HIGH DENSITY LIPOPROTEIN CHOLESTEROL (August 16, 1991)
  • K912725 — TOTAL IRON & UNSAT IRON BIND CAP/IRON BIND CONTROL (July 30, 1991)
  • K904989 — CLP LOW LEVEL HDL CHOLESTEROL-LIPID CONTROL-II (January 23, 1991)

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