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510(k) K020945

AXSYM INTACT PTH, MODEL 2G06 by Diagnostic Systems Laboratories, Inc. — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2002
Date Received
March 25, 2002
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

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  • K981607 — ACTIVE RENIN IRMA MODEL NUMBER DSL-25100 (May 27, 1998)
  • K973514 — ACTIVE INTACT PTH (October 31, 1997)

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