Audit Microcv Beta-Hydroxybutyric Acid Linearity Set
FDA 510(k) K130157 · Aalto Scientific, Ltd.
510(k) numberK130157
Submission
- Device name
- Audit Microcv Beta-Hydroxybutyric Acid Linearity Set
- Applicant
- Aalto Scientific, Ltd.
Carlsbad, CA, US - Received
- January 23, 2013
- Decision date
- March 19, 2013
- 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 |
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| K161874 | Audit MicroControls Linearity DROP LQ Blood GlucoseJJX · Traditional | 08/10/2016SE |
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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 |
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Questions and answers
When was Audit Microcv Beta-Hydroxybutyric Acid Linearity Set cleared by the FDA?
Audit Microcv Beta-Hydroxybutyric Acid Linearity Set (K130157) received a 510(k) decision of Substantially Equivalent on March 19, 2013, 55 days after the submission was received.
What is the product code of K130157?
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.