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510(k) K050748

ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 by Scantibodies Laboratory, Inc. — Product Code CKG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2005
Date Received
March 22, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Acth
Device Class
Class II
Regulation Number
862.1025
Review Panel
CH
Submission Type

Other clearances by Scantibodies Laboratory, Inc.

  • K060578 — CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) (August 30, 2006)
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  • 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)
  • 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 CKG

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  • K060585 — ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH (May 3, 2006)
  • K021032 — ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 (June 3, 2002)
  • K002638 — FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT (January 17, 2001)
  • K982608 — SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT (August 19, 1998)
  • K962601 — NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONE (December 24, 1996)
  • K960491 — MICRO HAEMATOCRIT CENTRIFUGE (October 18, 1996)
  • K960066 — IMMULITE ACTH (February 16, 1996)
  • K940271 — INCSTAR ACTH IRMA (August 2, 1994)