FDA 510(k) K000471, FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT, by Future Diagnostics B.V.
FDA 510(k) K000471, FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT, by Future Diagnostics B.V.
Device Classification Name: Radioimmunoassay, Parathyroid Hormone
510(k) Number: K000471
Device Name: FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT
Applicant: Future Diagnostics B.V.
Regulation Number: 862.1545
Classification Product Code: CEW
Date Received: 02/14/2000
Decision Date: 04/11/2000
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
510k Review Panel: Clinical Chemistry
Total number of pages: 16
Fully redacted pages: 1
Content pages: 15
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