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510(k) K861770

PHENYTOIN (FPIA) CALIBRATOR KIT by Windsor Laboratories, Inc. — Product Code JIS

K861770 is an FDA 510(k) premarket notification submitted by Windsor Laboratories, Inc. for the device "PHENYTOIN (FPIA) CALIBRATOR KIT". The FDA issued a decision of Substantially Equivalent on June 25, 1986. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. Windsor Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1986
Date Received
May 7, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
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)
  • 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 JIS

  • K122126 — DIRECT LDL/HDL CHOLESTEROL CALIBRATOR (August 14, 2012)
  • K061251 — DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR (May 31, 2006)
  • K060266 — DIMENSION IRON CALIBRATOR (March 9, 2006)
  • K053104 — DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR (December 23, 2005)
  • K032697 — DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) (November 7, 2003)
  • K032608 — GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER (October 21, 2003)
  • K032296 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS (August 13, 2003)
  • K030964 — CALIBRATION PLASMA LMW HEPARIN (June 6, 2003)
  • K030546 — CRP (II) CALIBRATORS (June 2, 2003)
  • K030320 — WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CON (April 11, 2003)

FDA data resources