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510(k) K895572

N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT by Tudor Laboratories, Inc. — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1989
Date Received
September 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Specific
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

Other clearances by Tudor Laboratories, Inc.

  • K921904 — THYROXINE (FPIA) KIT (June 24, 1992)
  • K921903 — THYROXINE CALIBRATOR KIT (May 26, 1992)
  • K913240 — DIGITOXIN (FPIA) KIT (September 6, 1991)
  • 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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  • K033601 — LABONE MICRO-PLATE COTININE EIA (February 10, 2004)