Scantibodies Laboratory, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION), MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002, MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
19
Total
19
Cleared
0
Denied
FDA 510(k) Regulatory Record - Scantibodies Laboratory, Inc. Chemistry ✕
17 devices
Cleared
Aug 30, 2006
CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
Chemistry
177d
Cleared
Mar 01, 2006
MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA)...
Chemistry
12d
Cleared
Feb 27, 2006
MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
Chemistry
17d
Cleared
Oct 18, 2005
TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
Chemistry
98d
Cleared
Sep 09, 2005
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT,...
Chemistry
66d
Cleared
Jul 26, 2005
WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002
Chemistry
83d
Cleared
Jul 26, 2005
TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
Chemistry
83d
Cleared
May 20, 2005
ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011
Chemistry
59d
Cleared
Jul 30, 2003
CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
Chemistry
75d
Cleared
Jun 03, 2002
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
Chemistry
66d
Cleared
Apr 30, 2001
TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
Chemistry
123d
Cleared
Aug 21, 2000
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL...
Chemistry
109d