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Scantibodies Laboratory, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
5
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K060578CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)August 30, 2006
K060420MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002March 1, 2006
K060348MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KITFebruary 27, 2006
K051888TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013October 18, 2005
K051810WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014September 9, 2005
K051150TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KITJuly 26, 2005
K051141WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002July 26, 2005
K050748ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011May 20, 2005
K031534CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001July 30, 2003
K021032ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100June 3, 2002
K004038TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600April 30, 2001
K001411WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056August 21, 2000
K974262SYSCOS IDC - G, IDC, BSC, IDC - GDecember 24, 1997
K962464SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY)October 8, 1996
K961043SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)May 6, 1996
K955812SYSCON TURMOR MARKER CONTROLMarch 12, 1996
K954247SYSCON CONTROL ASSAYED & UNASSAYEDFebruary 14, 1996
K944788INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY)July 19, 1995
K942647COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTIJuly 12, 1995