Vitros Immunodiagnostic Products Hbsag Controls
FDA 510(k) K030067 · Ortho-Clinical Diagnostics
510(k) numberK030067
Submission
- Device name
- Vitros Immunodiagnostic Products Hbsag Controls
- Applicant
- Ortho-Clinical Diagnostics
Rochester, NY, US - Received
- January 7, 2003
- Decision date
- January 17, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K101434 | Audit Microcv Procalcitonin LinearityMJX · Traditional | Aalto Scientific, Ltd. | 07/22/2010SE |
| K974262 | Syscos Idc - G, Idc, BSC, Idc - GMJX · Traditional | Scantibodies Laboratory, Inc. | 12/24/1997SE |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI · Traditional | 10/29/2025SE |
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent PackLIP · Traditional | 08/28/2024SE |
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackDHA · Traditional | 05/08/2024SE |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent PackCEW · Traditional | 09/05/2023SE |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent PackDHX · Traditional | 08/23/2023SE |
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent PackNIG · Traditional | 08/09/2023SE |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent PackLTK · Traditional | 12/12/2022SE |
| K213626 | Vitros AfpLOJ · Traditional | 06/15/2022SE |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent PackJHX · Traditional | 01/28/2022SE |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent PackNBC · Traditional | 10/04/2021SE |
Questions and answers
When was Vitros Immunodiagnostic Products Hbsag Controls cleared by the FDA?
Vitros Immunodiagnostic Products Hbsag Controls (K030067) received a 510(k) decision of Substantially Equivalent on January 17, 2003, 10 days after the submission was received.
What is the product code of K030067?
The FDA product code is MJX – Kit, Serological, Positive Control, a Class I (low risk) device regulated under 21 CFR 862.1660.