Liqui-Sera Serum Alcohol Controls
FDA 510(k) K881430 · Biodiagnostic Intl
510(k) numberK881430
Submission
- Device name
- Liqui-Sera Serum Alcohol Controls
- Applicant
- Biodiagnostic Intl
La Habra, CA, US - Received
- April 5, 1988
- Decision date
- July 8, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K031296 | Liqui-Heme Glyco A1C AssayLCP · Traditional | 10/15/2004SE |
| K874459 | Liqui-Sera Spinal Fluid ControlJJY · Traditional | 12/29/1987SE |
| K863849 | Liqui-Sera Combo Ligand/Tdm ControlsJJY · Traditional | 11/24/1986SE |
| K853906 | Liqui-Sera Chemistry Controls (Comprehensive)JJY · Traditional | 10/04/1985SE |
| K853887 | Liqui-Sera Chem. Multiple CalibratorsJIT · Traditional | 09/30/1985SE |
| K842668 | Liqui-Heme Hemoglobin CalibratorsKRZ · Traditional | 03/05/1985SE |
| K840618 | Liqui-Ura Chemistry Urine ControlsJJW · Traditional | 04/04/1984SE |
| K834398 | Liqui-Sera TDM CalibratorsDKB · Traditional | 02/03/1984SE |
| K834259 | Liqui-Ura Toxic Urine ControlDIF · Traditional | 01/30/1984SE |
| K831278 | Liqui-Sera Anticonvulsants ControlsDIF · Traditional | 05/27/1983SE |
Questions and answers
When was Liqui-Sera Serum Alcohol Controls cleared by the FDA?
Liqui-Sera Serum Alcohol Controls (K881430) received a 510(k) decision of Substantially Equivalent on July 8, 1988, 94 days after the submission was received.
What is the product code of K881430?
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.