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510(k) K000471

FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT by Future Diagnostics B.V. — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2000
Date Received
February 14, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Parathyroid Hormone
Device Class
Class II
Regulation Number
862.1545
Review Panel
CH
Submission Type

Other clearances by Future Diagnostics B.V.

  • K002638 — FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT (January 17, 2001)

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