Home / 510(k) Clearances / K863625

510(k) K863625

PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT by Windsor Laboratories, Inc. — Product Code LGQ

K863625 is an FDA 510(k) premarket notification submitted by Windsor Laboratories, Inc. for the device "PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on November 10, 1986. The device falls under product code LGQ (Fluorescence Polarization Immunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Windsor Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1986
Date Received
September 17, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Phenobarbital
Device Class
Class II
Regulation Number
862.3660
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)
  • K870389 — DIGOXIN (FPIA) CALIBRATOR KIT (April 1, 1987)
  • K870390 — PHENOBARBITAL (FPIA) CALIBRATOR KIT (April 1, 1987)
  • K864333 — DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY (January 5, 1987)
  • K863244 — AMIKACIN (FPIA) CALIBRATOR KIT (August 29, 1986)
  • K862248 — AMIKACIN KIT (FPIA) (August 4, 1986)
  • K861768 — THEOPHYLLINE (FPIA) CALIBRATOR KIT (June 25, 1986)
  • K861770 — PHENYTOIN (FPIA) CALIBRATOR KIT (June 25, 1986)

Other clearances for product code LGQ

  • K972331 — INNOFLUOR GENTAMICIN ASSAY SYSTEM (August 1, 1997)
  • K972330 — INNOFLUOR PHENOBARBITAL ASSAY SYSTEM (July 14, 1997)
  • K940596 — AXSYM PHENOBARBITAL (June 21, 1994)
  • K936130 — COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS (March 11, 1994)
  • K900704 — MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA (April 12, 1990)
  • K894525 — FPR PHENOBARBITAL KIT (August 28, 1989)
  • K872397 — COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI. (July 21, 1987)
  • K862528 — IMMPULSE PHENOBARBITAL ASSAY REAGENTS (July 16, 1986)
  • K854044 — TDX BARBITURATES (October 28, 1985)
  • K843825 — COBAS REAGENTS PHENOBARBITAL & PHENOBAR (February 1, 1985)

FDA data resources