Company ยท US
Scantibodies Laboratory, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2006. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 30, 2006 | K060578 | CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) Scantibodies Laboratory, Inc. | JKR |
| Mar 1, 2006 | K060420 | MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002 Scantibodies Laboratory, Inc. | CEW |
| Feb 27, 2006 | K060348 | MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT Scantibodies Laboratory, Inc. | CEW |
| Oct 18, 2005 | K051888 | TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 Scantibodies Laboratory, Inc. | CEW |
| Sep 9, 2005 | K051810 | WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014 Scantibodies Laboratory, Inc. | CEW |
| Jul 26, 2005 | K051150 | TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT Scantibodies Laboratory, Inc. | CEW |
| Jul 26, 2005 | K051141 | WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002 Scantibodies Laboratory, Inc. | CEW |
| May 20, 2005 | K050748 | ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 Scantibodies Laboratory, Inc. | CKG |
| Jul 30, 2003 | K031534 | CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001 Scantibodies Laboratory, Inc. | CEW |
| Jun 3, 2002 | K021032 | ACTH IMMUNORADIOMETRIC (IRMA) DIAGNOSTIC ASSAY KIT, MODEL #3KG100 Scantibodies Laboratory, Inc. | CKG |
| Apr 30, 2001 | K004038 | TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600 Scantibodies Laboratory, Inc. | CEW |
| Aug 21, 2000 | K001411 | WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056 Scantibodies Laboratory, Inc. | CEW |
| Dec 24, 1997 | K974262 | SYSCOS IDC - G, IDC, BSC, IDC - G Scantibodies Laboratory, Inc. | MJX |
| Oct 8, 1996 | K962464 | SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY) Scantibodies Laboratory, Inc. | JLW |
| May 6, 1996 | K961043 | SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY) Scantibodies Laboratory, Inc. | JKR |
| Mar 12, 1996 | K955812 | SYSCON TURMOR MARKER CONTROL Scantibodies Laboratory, Inc. | JJY |
| Feb 14, 1996 | K954247 | SYSCON CONTROL ASSAYED & UNASSAYED Scantibodies Laboratory, Inc. | JJY |
| Jul 19, 1995 | K944788 | INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY) Scantibodies Laboratory, Inc. | CEW |
| Jul 12, 1995 | K942647 | COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI Scantibodies Laboratory, Inc. | JJY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||