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510(k) K070391

ELECSYS PTH TEST SYSTEM by Roche Diagnostics Corp. — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2007
Date Received
February 9, 2007
Clearance Type
Special
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

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  • K133601 — ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY (February 5, 2014)
  • K132515 — LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS (November 8, 2013)
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