Document Chem II Calibration Verification Test Set
FDA 510(k) K923794 · Casco Standards
510(k) numberK923794
Submission
- Device name
- Document Chem II Calibration Verification Test Set
- Applicant
- Casco Standards
Yarmouth, ME, US - Received
- July 28, 1992
- Decision date
- November 5, 1992
- 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
Other 510(k)s with product code JJX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170678 | Beta-CrossLaps CalCheck 5JJX · Traditional | Roche Diagnostics | 04/04/2017SE |
| K162173 | Elecsys CYFRA 21-1 CalCheck 5JJX · Traditional | Roche Diagnostics | 01/12/2017SE |
| 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 |
|---|---|---|
| K981436 | Document Ammonia/Ethanol/Lactate Calibrator, PN: M-109JIX · Special | 04/24/1998SE |
| K972904 | Document Molecular Pathology Chlamydia Trachomatis ControlJJY · Traditional | 02/20/1998SE |
| K962629 | Document Ammonia, Ethanol, Lactate CalibratorJIX · Traditional | 09/13/1996SE |
| K962630 | Document Ammonia, Ethanol, Lactate Assayed ControlJJY · Traditional | 07/22/1996SE |
| K961750 | Document Cardiac Assayed ControlJJY · Traditional | 07/22/1996SE |
| K960244 | Document TDM Ultra Assayed ControlDIF · Traditional | 03/22/1996SE |
| K955155 | Document TDM Ultra Unassayed ControlDIF · Traditional | 12/20/1995SE |
| K950469 | Document Serum Multianalyte Calibration Verification Test SetJJY · Traditional | 04/11/1995SE |
| K945718 | Document(R) HDL Cholesterol Calibration Verification Test SetJJX · Traditional | 01/17/1995SE |
| K945315 | Document(R) Ammonia/Ethanol Aqueous ControlJJY · Traditional | 12/09/1994SE |
Questions and answers
When was Document Chem II Calibration Verification Test Set cleared by the FDA?
Document Chem II Calibration Verification Test Set (K923794) received a 510(k) decision of Substantially Equivalent on November 5, 1992, 100 days after the submission was received.
What is the product code of K923794?
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.