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510(k) K060420

MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002 by Scantibodies Laboratory, Inc. — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2006
Date Received
February 17, 2006
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

Other clearances by Scantibodies Laboratory, Inc.

  • K060578 — CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) (August 30, 2006)
  • K060348 — MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT (February 27, 2006)
  • K051888 — TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 (October 18, 2005)
  • K051810 — WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL (September 9, 2005)
  • K051150 — TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT (July 26, 2005)
  • K051141 — WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002 (July 26, 2005)
  • K050748 — ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 (May 20, 2005)
  • K031534 — CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001 (July 30, 2003)
  • K021032 — ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 (June 3, 2002)
  • K004038 — TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600 (April 30, 2001)

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