Audit Microcv Procalcitonin Linearity
FDA 510(k) K101434 · Aalto Scientific, Ltd.
510(k) numberK101434
Submission
- Device name
- Audit Microcv Procalcitonin Linearity
- Applicant
- Aalto Scientific, Ltd.
Carlsbad, CA, US - Received
- May 21, 2010
- Decision date
- July 22, 2010
- 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
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| K030067 | Vitros Immunodiagnostic Products Hbsag ControlsMJX · Traditional | Ortho-Clinical Diagnostics | 01/17/2003SE |
| 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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Questions and answers
When was Audit Microcv Procalcitonin Linearity cleared by the FDA?
Audit Microcv Procalcitonin Linearity (K101434) received a 510(k) decision of Substantially Equivalent on July 22, 2010, 62 days after the submission was received.
What is the product code of K101434?
The FDA product code is MJX – Kit, Serological, Positive Control, a Class I (low risk) device regulated under 21 CFR 862.1660.