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510(k) K943704

LIPASE CALIBRATOR by The DU Pont Co. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1994
Date Received
August 1, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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  • K884700 — ANALYST THYROXINE (T4) ROTOR (January 27, 1989)
  • K884169 — DU PONT ANALYST THYROID ROTOR (January 24, 1989)
  • K884168 — ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA. (November 29, 1988)

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