Sugar-Chex II
FDA 510(k) K851043 · Streck Laboratories, Inc.
510(k) numberK851043
Submission
- Device name
- Sugar-Chex II
- Applicant
- Streck Laboratories, Inc.
Omaha, NE, US - Received
- March 14, 1985
- Decision date
- April 29, 1985
- 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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| K162514 | Multichem A1cJJX · Abbreviated | Technopath Manufacturing | 10/26/2016SE |
| 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 |
|---|---|---|
| K042587 | Retic-Chex for Cell-DynJPK · Traditional | 10/19/2004SE |
| K040107 | Cyto-Chex BCTJKA · Traditional | 07/27/2004SE |
| K040025 | A1C-CELLULARJJX · Traditional | 03/02/2004SE |
| K023656 | Sickle-Chex Solubility KitGHM · Traditional | 12/30/2002SE |
| K021922 | Modification to Para 5XJPK · Special | 06/25/2002SE |
| K020469 | Cal-Chex CD PlusKRX · Traditional | 04/04/2002SE |
| K013316 | Sickle-ChexGHM · Traditional | 11/06/2001SE |
| K011410 | Para 5XJPK · Traditional | 06/26/2001SE |
| K001443 | Sugar Chex OneJJX · Traditional | 06/29/2000SE |
| K000945 | Para 12 Plus ReticsGLQ · Traditional | 04/18/2000SE |
Questions and answers
When was Sugar-Chex II cleared by the FDA?
Sugar-Chex II (K851043) received a 510(k) decision of Substantially Equivalent on April 29, 1985, 46 days after the submission was received.
What is the product code of K851043?
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.