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Scantibodies Laboratory, Inc.

FDA 510(k) & PMA Approved Devices — 19 products

Total Devices19
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K060578 CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION)JKR2006-08-30 View
510(k) K060420 MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002CEW2006-03-01 View
510(k) K060348 MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KITCEW2006-02-27 View
510(k) K051888 TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013CEW2005-10-18 View
510(k) K051810 WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014CEW2005-09-09 View
510(k) K051141 WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002CEW2005-07-26 View
510(k) K051150 TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KITCEW2005-07-26 View
510(k) K050748 ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011CKG2005-05-20 View
510(k) K031534 CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001CEW2003-07-30 View
510(k) K021032 ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100CKG2002-06-03 View
510(k) K004038 TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600CEW2001-04-30 View
510(k) K001411 WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056CEW2000-08-21 View
510(k) K974262 SYSCOS IDC - G, IDC, BSC, IDC - GMJX1997-12-24 View
510(k) K962464 SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY)JLW1996-10-08 View
510(k) K961043 SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)JKR1996-05-06 View
510(k) K955812 SYSCON TURMOR MARKER CONTROLJJY1996-03-12 View
510(k) K954247 SYSCON CONTROL ASSAYED & UNASSAYEDJJY1996-02-14 View
510(k) K944788 INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY)CEW1995-07-19 View
510(k) K942647 COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTIJJY1995-07-12 View
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