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510(k) K894528

FPR PHENYTOIN CALIBRATOR KIT by Colony Laboratories, Inc. — Product Code DLG

K894528 is an FDA 510(k) premarket notification submitted by Colony Laboratories, Inc. for the device "FPR PHENYTOIN CALIBRATOR KIT". The FDA issued a decision of Substantially Equivalent on September 25, 1989. The device falls under product code DLG (Coating, Liquid, Glc), a Class I device regulated under 21 CFR 862.2250. Colony Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1989
Date Received
July 20, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coating, Liquid, Glc
Device Class
Class I
Regulation Number
862.2250
Review Panel
TX
Submission Type

Other clearances by Colony Laboratories, Inc.

  • K894524 — FPR GENTAMICIN CALIBRATOR KIT (September 28, 1989)
  • K894517 — FPR AMIKACIN KIT (September 28, 1989)
  • K894518 — FPR AMIKACIN CALIBRATOR KIT (September 28, 1989)
  • K894523 — FPR GENTAMICIN KIT (September 28, 1989)
  • K894527 — FPR PHENYTOIN KIT (September 25, 1989)
  • K894521 — FPR DIGOXIN KIT (September 25, 1989)
  • K894522 — FPR DIGOXIN CALIBRATOR KIT (September 25, 1989)
  • K894530 — FPR THEOPHYLLINE CALIBRATOR KIT (September 18, 1989)
  • K894529 — FPR THEOPHYLLINE KIT (September 15, 1989)
  • K894532 — FPR TOBRAMYCIN CALIBRATOR KIT (September 1, 1989)

Other clearances for product code DLG

  • K050988 — OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS (April 6, 2006)
  • K920419 — IL TEST DAT CAL/CONTROL SET D/E (March 11, 1992)
  • K894518 — FPR AMIKACIN CALIBRATOR KIT (September 28, 1989)
  • K894524 — FPR GENTAMICIN CALIBRATOR KIT (September 28, 1989)
  • K882766 — EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 (August 23, 1988)
  • K833385 — N-ACETYLPROCAINAMIDE CALIBRATOR (December 16, 1983)

FDA data resources