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510(k) K894530

FPR THEOPHYLLINE CALIBRATOR KIT by Colony Laboratories, Inc. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Colony Laboratories, Inc.

  • K894518 — FPR AMIKACIN CALIBRATOR KIT (September 28, 1989)
  • K894523 — FPR GENTAMICIN KIT (September 28, 1989)
  • K894517 — FPR AMIKACIN KIT (September 28, 1989)
  • K894524 — FPR GENTAMICIN CALIBRATOR KIT (September 28, 1989)
  • K894522 — FPR DIGOXIN CALIBRATOR KIT (September 25, 1989)
  • K894527 — FPR PHENYTOIN KIT (September 25, 1989)
  • K894528 — FPR PHENYTOIN CALIBRATOR KIT (September 25, 1989)
  • K894521 — FPR DIGOXIN KIT (September 25, 1989)
  • K894529 — FPR THEOPHYLLINE KIT (September 15, 1989)
  • K894532 — FPR TOBRAMYCIN CALIBRATOR KIT (September 1, 1989)

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