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510(k) K870389

DIGOXIN (FPIA) CALIBRATOR KIT by Windsor Laboratories, Inc. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1987
Date Received
January 30, 1987
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 Windsor Laboratories, Inc.

  • K873281 — CARBAMAZEPINE (FPIA) CALIBRATOR KIT (October 28, 1987)
  • K873282 — CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY (September 22, 1987)
  • K871486 — (FPIA) ASSAY BUFFER (May 8, 1987)
  • K870390 — PHENOBARBITAL (FPIA) CALIBRATOR KIT (April 1, 1987)
  • K864333 — DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY (January 5, 1987)
  • K863625 — PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT (November 10, 1986)
  • K863244 — AMIKACIN (FPIA) CALIBRATOR KIT (August 29, 1986)
  • K862248 — AMIKACIN KIT (FPIA) (August 4, 1986)
  • K861770 — PHENYTOIN (FPIA) CALIBRATOR KIT (June 25, 1986)
  • K861768 — THEOPHYLLINE (FPIA) CALIBRATOR KIT (June 25, 1986)

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  • K033601 — LABONE MICRO-PLATE COTININE EIA (February 10, 2004)