JJX — Single (Specified) Analyte Controls (Assayed And Unassayed) Class I
FDA product code JJX covers "Single (Specified) Analyte Controls (Assayed And Unassayed)", a Class I medical device regulated under 21 CFR 862.1660. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JJX
- Device Class
- Class I
- Regulation Number
- 862.1660
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K170678 | roche diagnostics | Beta-CrossLaps CalCheck 5 | April 4, 2017 |
| K162173 | roche diagnostics | Elecsys CYFRA 21-1 CalCheck 5 | January 12, 2017 |
| K162514 | technopath manufacturing | Multichem A1c | October 26, 2016 |
| K161874 | aalto scientific | Audit MicroControls Linearity DROP LQ Blood Glucose | August 10, 2016 |
| K161522 | diasorin | LIAISON EBV IgM Serum Control Set | June 30, 2016 |
| K161526 | diasorin | LIAISON CMV IgM Serum Control Set | June 30, 2016 |
| K161082 | immunodiagnostic systems | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration | May 17, 2016 |
| K152117 | quantimetrix corporation | Dropper hsCRP High Sensitivity CRP Control | April 21, 2016 |
| K151742 | bayer healthcare | Contour Next Control Solution | September 23, 2015 |
| K143687 | siemens healthcare diagnostics | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Ce | July 17, 2015 |
| K150955 | roche diagnostics | Elecsys Progesterone III Cal Check 5 | May 1, 2015 |
| K150132 | siemens healthcare diagnostics | IMMULITE IGF Control Module, IMMULITE Gastrin Control Module | April 13, 2015 |
| K143324 | immunodiagnostic systems | IDS-iSYS CTX-I Calibration Verifiers | March 30, 2015 |
| K143373 | siemens healthcare diagnostics | IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Pro | February 26, 2015 |
| K143636 | siemens healthcare diagnostics | IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 T | February 25, 2015 |
| K143680 | siemens healthcare diagnostics | ADVIA Centaur IgE Master Curve Material | January 27, 2015 |
| K143571 | aalto scientific | Audit MicroControls Linearity LQ Cystatin-C | January 23, 2015 |
| K143639 | siemens healthcare diagnostics | IMMULITE 2000 CEA Calibration Verification Material | January 23, 2015 |
| K143504 | siemens healthcare diagnostics | IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin | January 14, 2015 |
| K143352 | siemens healthcare diagnostics | IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 | December 24, 2014 |