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510(k) K921903

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

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)
  • K895568 — PRIMIDONE (FPIA) CALIBRATOR KIT (September 28, 1989)
  • K895570 — VALPROIC ACID (FPIA) CALIBRATOR KIT (September 28, 1989)

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