Medical Device Manufacturer · US , Santee , CA

Scantibodies Laboratory, Inc. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 1995
19
Total
19
Cleared
0
Denied

Scantibodies Laboratory, Inc. has 19 FDA 510(k) cleared chemistry devices. Based in Santee, US.

Historical record: 19 cleared submissions from 1995 to 2006.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Scantibodies Laboratory, Inc.

19 devices
1-19 of 19
Cleared Aug 30, 2006
CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)
K060578 · JKR
Chemistry · 177d
Cleared Mar 01, 2006
MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA)...
K060420 · CEW
Chemistry · 12d
Cleared Feb 27, 2006
MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
K060348 · CEW
Chemistry · 17d
Cleared Oct 18, 2005
TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
K051888 · CEW
Chemistry · 98d
Cleared Sep 09, 2005
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT,...
K051810 · CEW
Chemistry · 66d
Cleared Jul 26, 2005
WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002
K051141 · CEW
Chemistry · 83d
Cleared Jul 26, 2005
TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
K051150 · CEW
Chemistry · 83d
Cleared May 20, 2005
ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011
K050748 · CKG
Chemistry · 59d
Cleared Jul 30, 2003
CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
K031534 · CEW
Chemistry · 75d
Cleared Jun 03, 2002
ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100
K021032 · CKG
Chemistry · 66d
Cleared Apr 30, 2001
TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
K004038 · CEW
Chemistry · 123d
Cleared Aug 21, 2000
WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL...
K001411 · CEW
Chemistry · 109d
Cleared Dec 24, 1997
SYSCOS IDC - G, IDC, BSC, IDC - G
K974262 · MJX
Microbiology · 41d
Cleared Oct 08, 1996
SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE...
K962464 · JLW
Chemistry · 105d
Cleared May 06, 1996
SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)
K961043 · JKR
Chemistry · 53d
Cleared Mar 12, 1996
SYSCON TURMOR MARKER CONTROL
K955812 · JJY
Chemistry · 77d
Cleared Feb 14, 1996
SYSCON CONTROL ASSAYED & UNASSAYED
K954247 · JJY
Chemistry · 156d
Cleared Jul 19, 1995
INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY)
K944788 · CEW
Chemistry · 294d
Cleared Jul 12, 1995
COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI
K942647 · JJY
Immunology · 404d
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