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510(k) K842586

PHENYTOIN KIT FLUORESCENCE POLARIZATION by Windsor Laboratories, Inc. — Product Code LGR

K842586 is an FDA 510(k) premarket notification submitted by Windsor Laboratories, Inc. for the device "PHENYTOIN KIT FLUORESCENCE POLARIZATION". The FDA issued a decision of Substantially Equivalent on September 26, 1984. The device falls under product code LGR (Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)), a Class II device regulated under 21 CFR 862.3350. Windsor Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1984
Date Received
July 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
Device Class
Class II
Regulation Number
862.3350
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)
  • K870389 — DIGOXIN (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)
  • K861768 — THEOPHYLLINE (FPIA) CALIBRATOR KIT (June 25, 1986)

Other clearances for product code LGR

  • K955873 — ACS PHENYTOIN ASSAY (March 11, 1996)
  • K955562 — INNOFLUOR PHENYTOIN ASSAY SYSTEM (January 24, 1996)
  • K953840 — AXSYM PHENYTOIN II (September 25, 1995)
  • K946328 — TDX(R)/TDXFLX(R) PHENYTOIN II (March 28, 1995)
  • K943313 — PHENYTOIN FPIA REAGENT SET AND CALIBRATORS (October 27, 1994)
  • K935375 — AXSYM PHENYTOIN ASSAY (June 21, 1994)
  • K936131 — COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS (March 11, 1994)
  • K896868 — OPUS PHENYTOIN TEST SYSTEM (January 2, 1990)
  • K895827 — INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET (October 31, 1989)
  • K872563 — INNOTRON INNOFLUOR PHEYTOIN REAGENT SET (August 21, 1987)

FDA data resources