Liquispex Urine (Micro)Albumin Control
FDA 510(k) K962432 · Clinical Controls, Inc.
510(k) numberK962432
Submission
- Device name
- Liquispex Urine (Micro)Albumin Control
- Applicant
- Clinical Controls, Inc.
Grover Beach, CA, US - Received
- June 24, 1996
- Decision date
- July 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K162514 | Multichem A1cJJX · Abbreviated | Technopath Manufacturing | 10/26/2016SE |
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| 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 |
|---|---|---|
| K012907 | Liquispx Liquid Saliva or Unrine Drug of Abuse ControlDIF · Traditional | 09/28/2001SE |
| K964278 | Whole Blood Glucose Control Level 1,2,AND 3/WHOLE Blood Glucose Linearity…JJX · Traditional | 11/22/1996SE |
| K955691 | Serum Volatiles Control Level 1 & 2JJY · Traditional | 04/24/1996SE |
| K955690 | Aqueous Ethanol/Ammonia Control Level 1, 2, & 3JJY · Traditional | 04/24/1996SE |
| K946265 | Fibrinogen High Abnormal Control - Level 3GIL · Traditional | 08/24/1995SE |
| K935598 | Plasma Fibrinogen Control Level 1/LEVEL 2GIL · Traditional | 05/02/1995SE |
| K946266 | Ferritin Control - Level 1, 2, 3DGD · Traditional | 02/10/1995SE |
| K946050 | Liquispex(Tm) Liquid CRP Control Level 1 and 2DCK · Traditional | 02/10/1995SE |
| K946049 | Liquispex(Tm) Liquid B2M/CRP Control Level 1 and 2JJY · Traditional | 02/10/1995SE |
| K946048 | Liquispex(Tm) Liquid B2M Control Level 1 and 2JZG · Traditional | 02/10/1995SE |
Questions and answers
When was Liquispex Urine (Micro)Albumin Control cleared by the FDA?
Liquispex Urine (Micro)Albumin Control (K962432) received a 510(k) decision of Substantially Equivalent on July 5, 1996, 11 days after the submission was received.
What is the product code of K962432?
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.