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510(k) K894527

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

K894527 is an FDA 510(k) premarket notification submitted by Colony Laboratories, Inc. for the device "FPR PHENYTOIN KIT". The FDA issued a decision of Substantially Equivalent on September 25, 1989. The device falls under product code DLP (Radioimmunoassay, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. 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
Radioimmunoassay, Diphenylhydantoin
Device Class
Class II
Regulation Number
862.3350
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)
  • K894528 — FPR PHENYTOIN CALIBRATOR 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 DLP

  • K811775 — KALLESTAD ANTISERA TO PHENYTOIN (July 10, 1981)
  • K792640 — FLUOROMATIC PHENYTOIN FIA (January 11, 1980)
  • K791896 — CENTRIA PHENYTOIN RIA TEST SET (October 17, 1979)
  • K770779 — PHENYTOIN RIA KIT (June 17, 1977)

FDA data resources