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510(k) K060578

CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) by Scantibodies Laboratory, Inc. — Product Code JKR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 2006
Date Received
March 6, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Calcitonin
Device Class
Class II
Regulation Number
862.1140
Review Panel
CH
Submission Type

Other clearances by Scantibodies Laboratory, Inc.

  • K060420 — MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY (March 1, 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)

Other clearances for product code JKR

  • K182012 — ADVIA Centaur Calcitonin (CALCT) assay (December 21, 2018)
  • K132828 — ELECSYS CALCITONIN; IMMUNOASSAY, CALSET, CALCHECK 5; ELECSYS PRECICONTROL VARIA (December 4, 2013)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE (December 9, 2002)
  • K990073 — CALCITONIN (May 11, 1999)
  • K982491 — SANGUI BIOTECH, INC. CALCITONIN ELISA KIT (September 3, 1998)
  • K964635 — NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT (May 21, 1997)
  • K961043 — SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY) (May 6, 1996)
  • K945961 — CALCITONIN IMMUNOASSAY KIT (November 20, 1995)
  • K951708 — ELSA-HCT (September 5, 1995)
  • K914429 — DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) (January 15, 1992)