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510(k) K880711

CLP 0.02 M CALCIUM CHLORIDE SOLUTION. by Creative Laboratory Products, Inc. — Product Code GIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1988
Date Received
February 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent & Control, Partial Thromboplastin Time
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
Submission Type

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  • 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)

Other clearances for product code GIT

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