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510(k) K921903

THYROXINE CALIBRATOR KIT by Tudor Laboratories, Inc. — Product Code JIS

K921903 is an FDA 510(k) premarket notification submitted by Tudor Laboratories, Inc. for the device "THYROXINE CALIBRATOR KIT". The FDA issued a decision of Substantially Equivalent on May 26, 1992. The device falls under product code JIS (Calibrator, Primary), a Class II device regulated under 21 CFR 862.1150. Tudor Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1992
Date Received
April 21, 1992
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 Tudor Laboratories, Inc.

  • K921904 — THYROXINE (FPIA) KIT (June 24, 1992)
  • K913240 — DIGITOXIN (FPIA) KIT (September 6, 1991)
  • K895572 — N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT (October 30, 1989)
  • K895571 — N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT (October 25, 1989)
  • K895567 — PRIMIDONE (FPIA) KIT (October 20, 1989)
  • K895569 — VALPROIC ACID (FPIA) KIT (October 3, 1989)
  • K895570 — VALPROIC ACID (FPIA) CALIBRATOR KIT (September 28, 1989)
  • K895568 — PRIMIDONE (FPIA) CALIBRATOR KIT (September 28, 1989)

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