Audit Microcv Hs-Crp Linearity Set
FDA 510(k) K101427 · Aalto Scientific, Ltd.
510(k) numberK101427
Submission
- Device name
- Audit Microcv Hs-Crp Linearity Set
- Applicant
- Aalto Scientific, Ltd.
Carlsbad, CA, US - Received
- May 21, 2010
- Decision date
- December 23, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K161874 | Audit MicroControls Linearity DROP LQ Blood GlucoseJJX · Traditional | Aalto Scientific, Ltd. | 08/10/2016SE |
| K161526 | LIAISON CMV IgM Serum Control SetJJX · Special | DiaSorin, Inc. | 06/30/2016SE |
| K161522 | LIAISON EBV IgM Serum Control SetJJX · Special | DiaSorin, Inc. | 06/30/2016SE |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersJJX · Traditional | Immunodiagnostic Systems , Ltd. | 05/17/2016SE |
| K152117 | Dropper hsCRP High Sensitivity CRP ControlJJX · Traditional | Quantimetrix Corporation | 04/21/2016SE |
| K151742 | Contour Next Control SolutionJJX · Traditional | Bayer Healthcare | 09/23/2015SE |
| K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…JJX · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/17/2015SE |
More from Siemens Healthcare Diagnostics, Inc.
| 510(k) | Device | Decision |
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| K161874 | Audit MicroControls Linearity DROP LQ Blood GlucoseJJX · Traditional | 08/10/2016SE |
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| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | 01/16/2015SE |
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| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | 11/20/2014SE |
| K130762 | Audit Microcv Therapeutic Drug (TDM) Linearity SetJJY · Traditional | 04/29/2013SE |
| K130764 | Audit Microcv Vitamin D Linearity SetJJX · Traditional | 04/26/2013SE |
| K130157 | Audit Microcv Beta-Hydroxybutyric Acid Linearity SetJJX · Traditional | 03/19/2013SE |
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Questions and answers
When was Audit Microcv Hs-Crp Linearity Set cleared by the FDA?
Audit Microcv Hs-Crp Linearity Set (K101427) received a 510(k) decision of Substantially Equivalent on December 23, 2010, 216 days after the submission was received.
What is the product code of K101427?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.