Chemistry Calibrator
FDA 510(k) K020454 · Jas Diagnostics, Inc.
510(k) numberK020454
Submission
- Device name
- Chemistry Calibrator
- Applicant
- Jas Diagnostics, Inc.
Miami, FL, US - Received
- February 11, 2002
- Decision date
- April 8, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIT – Calibrator, Secondary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171168 | VITROS Immunodiagnostic Products Insulin CalibratorsJIT · Abbreviated | Ortho Clinical Diagnostics | 05/16/2017SE |
| K170938 | CalSet IGF-1JIT · Traditional | Roche Diagnostics | 04/26/2017SE |
| K170160 | Abbott ARCHITECT Free T3JIT · Traditional | Abbott Laboratories | 02/15/2017SE |
| K163546 | Lumipulse G Progesterone-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163534 | Lumipulse G FSH-N CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/13/2017SE |
| K163544 | Lumipulse G ProlactinJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163521 | Lumipulse G LH CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 01/12/2017SE |
| K163078 | Dc-Uibc-CalJIT · Abbreviated | Sekisui Diagnostics P.E.I., Inc. | 12/08/2016SE |
| K163053 | Lumipulse G E2-III CalibratorsJIT · Abbreviated | Fujirebio Diagnostics,Inc. | 12/01/2016SE |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorJIT · Special | Siemens Healthcare Diagnostics | 11/17/2016SE |
More from Siemens Healthcare Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K130915 | XL-200 Clinical Chemistry Analyzer, Jas Glucose Reagent, Ise Reagent PackJJE · Traditional | 05/15/2014SE |
| K080623 | Cholesterol Oxidase Jase, and Glycerol Inase Triglycerides, Model NaCHH · Traditional | 11/17/2008SE |
| K080618 | Direct HBA1C, Fructosamine, Glucose Oxidase LiquidLCP · Traditional | 05/23/2008SE |
| K022519 | LDL Cholesterol (Automated)JHM · Traditional | 09/30/2002SE |
| K021671 | Jas HDL Cholesterol (Automated) ReagentLBS · Traditional | 07/19/2002SE |
| K020282 | Jas Amylase Liquid ReagentJFJ · Traditional | 02/28/2002SE |
| K013912 | Creatine Kinase (Ck-Nac)CGS · Traditional | 01/18/2002SE |
| K013698 | Ast (Sgot)CIT · Traditional | 12/21/2001SE |
| K012332 | Jas Carbon Dioxide Liquid ReagentKHS · Traditional | 09/06/2001SE |
| K012038 | Jas Uric Acid Liquid ReagentKNK · Traditional | 08/21/2001SE |
Questions and answers
When was Chemistry Calibrator cleared by the FDA?
Chemistry Calibrator (K020454) received a 510(k) decision of Substantially Equivalent on April 8, 2002, 56 days after the submission was received.
What is the product code of K020454?
The FDA product code is JIT – Calibrator, Secondary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.