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510(k) K834398

LIQUI-SERA TDM CALIBRATORS by Biodiagnostic Intl — Product Code DKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1984
Date Received
December 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Mixture
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

Other clearances by Biodiagnostic Intl

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  • K874459 — LIQUI-SERA SPINAL FLUID CONTROL (December 29, 1987)
  • K863849 — LIQUI-SERA COMBO LIGAND/TDM CONTROLS (November 24, 1986)
  • K853906 — LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) (October 4, 1985)
  • K853887 — LIQUI-SERA CHEM. MULTIPLE CALIBRATORS (September 30, 1985)
  • K842668 — LIQUI-HEME HEMOGLOBIN CALIBRATORS (March 5, 1985)
  • K840618 — LIQUI-URA CHEMISTRY URINE CONTROLS (April 4, 1984)
  • K834259 — LIQUI-URA TOXIC URINE CONTROL (January 30, 1984)
  • K831278 — LIQUI-SERA ANTICONVULSANTS CONTROLS (May 27, 1983)

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