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510(k) K880712

CLP NORMAL COAGULATION CONTROL by Creative Laboratory Products, Inc. — Product Code GIZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1988
Date Received
February 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Control, Normal
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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  • K913371 — TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL (November 8, 1991)
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  • 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)

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