Syscos Idc - G, Idc, BSC, Idc - G
FDA 510(k) K974262 · Scantibodies Laboratory, Inc.
510(k) numberK974262
Submission
- Device name
- Syscos Idc - G, Idc, BSC, Idc - G
- Applicant
- Scantibodies Laboratory, Inc.
Santee, CA, US - Received
- November 13, 1997
- Decision date
- December 24, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MJX – Kit, Serological, Positive Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code MJX
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|---|---|---|---|
| K101434 | Audit Microcv Procalcitonin LinearityMJX · Traditional | Aalto Scientific, Ltd. | 07/22/2010SE |
| K030067 | Vitros Immunodiagnostic Products Hbsag ControlsMJX · Traditional | Ortho-Clinical Diagnostics | 01/17/2003SE |
| K972986 | Accurun 140 Rubella Igg Positive ControlMJX · Traditional | Boston Biomedica, Inc. | 10/08/1997SE |
| K970100 | Tech Simple Syphilis Positive Serum Control Monitor Ontrak Syphilis Positive Serum ControlMJX · Traditional | Simplicity Diagnostics, Inc. | 03/10/1997SE |
| K934137 | Opus(R) Serology Controls, ModificationMJX · Traditional | Pb Diagnostic Systems, Inc. | 03/07/1994SE |
| K925703 | Opus Serology ControlsMJX · Traditional | Pb Diagnostics, Inc. | 04/08/1993SE |
More from Pb Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K060578 | Calcitonin Immunoradiometric Assay (Irma) (Coated Tube Version)JKR · Traditional | 08/30/2006SE |
| K060420 | Modification to Whole PTH (1-84) Specific Immunochemilluminometric (Icma) Assay Kit…CEW · Special | 03/01/2006SE |
| K060348 | Modification to: Total Intact PTH Immunochemiluminometric (Icma) Assay KitCEW · Special | 02/27/2006SE |
| K051888 | Total Intact PTH Immunoradiometric Assay (Coated Tube Version), Model 3KG013CEW · Traditional | 10/18/2005SE |
| K051810 | Whole PTH (1-84) Specific Immunoradiometric Assay (Irma) Coated Tube Kit, Model 3KG014CEW · Traditional | 09/09/2005SE |
| K051150 | Total Intact PTH Immunochemiluminometric (Icma) Assay KitCEW · Traditional | 07/26/2005SE |
| K051141 | Whole PTH (1-84) Specific Immunochemiluminometric Assay (Icma), Model 3KG002CEW · Traditional | 07/26/2005SE |
| K050748 | Acth Immunoradiometric (Irma) Assay Kit, Model 3KG011CKG · Traditional | 05/20/2005SE |
| K031534 | Cyclase Activating PTH (Cap) Immunoradiometric (Irma) Assay Kit, Model 3KG001CEW · Traditional | 07/30/2003SE |
| K021032 | Acth Immunoradiometric (Irma) Diagnostic Assay Kit, Model #3KG100CKG · Traditional | 06/03/2002SE |
Questions and answers
When was Syscos Idc - G, Idc, BSC, Idc - G cleared by the FDA?
Syscos Idc - G, Idc, BSC, Idc - G (K974262) received a 510(k) decision of Substantially Equivalent on December 24, 1997, 41 days after the submission was received.
What is the product code of K974262?
The FDA product code is MJX – Kit, Serological, Positive Control, a Class I (low risk) device regulated under 21 CFR 862.1660.