CRP (II) Calibrators
FDA 510(k) K030546 · Denka Seiken Co., Ltd.
510(k) numberK030546
Submission
- Device name
- CRP (II) Calibrators
- Applicant
- Denka Seiken Co., Ltd.
Gosen City, Niigata, JP - Received
- February 20, 2003
- Decision date
- June 2, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIS – Calibrator, Primary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122126 | Direct Ldl/Hdl Cholesterol CalibratorJIS · Traditional | Randox Laboratories Limited | 08/14/2012SE |
| K061251 | Dimension Vista Total Iron Binding Capacity CalibratorJIS · Traditional | Dade Behring, Inc. | 05/31/2006SE |
| K060266 | Dimension Iron CalibratorJIS · Traditional | Dade Behring, Inc. | 03/09/2006SE |
| K053104 | Dimension Cardiophase High Sensitivity C-Reactive Protein CalibratorJIS · Traditional | Dade Behring, Inc. | 12/23/2005SE |
| K032697 | Dimension Total Triiodothyronine Calibrator (RC414)JIS · Traditional | Dade Behring, Inc. | 11/07/2003SE |
| K032608 | Gonotec Calibration Solution 300 Mosmol/Kg for OsmometerJIS · Abbreviated | Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB | 10/21/2003SE |
| K032296 | Vitros Immunodiagnostic Products Progestrone Reagent Pack and CalibratorsJIS · Special | Ortho-Clinical Diagnostics, Inc. | 08/13/2003SE |
| K030964 | Calibration Plasma LMW HeparinJIS · Traditional | Instrumentation Laboratory CO | 06/06/2003SE |
| K030320 | Wako Autokit Micro Albumin, Wako Autokit Micro Calibrator Set, Micro Albumin Control SetJIS · Traditional | Wako Chemicals USA, Inc. | 04/11/2003SE |
| K022682 | Randox C-Reactive Protein CalibratorJIS · Traditional | Randox Laboratories, Ltd. | 11/05/2002SE |
More from Randox Laboratories, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K161679 | s LDL-EX SEIKENPYP · Traditional | 08/18/2017SE |
| K060359 | Archiect Insulin and Controls, Model 8K41-01, 8K41-10JIT · Abbreviated | 04/14/2006SE |
| K043264 | Ldl-Ex Seiken Assay KitMRR · Traditional | 01/26/2005SE |
| K041090 | Hdl-Ex Seiken Assay KitLBS · Traditional | 10/29/2004SE |
| K030545 | Crp-Latex (II)X2 Seiken Assay KitDCK · Traditional | 06/02/2003SE |
Questions and answers
When was CRP (II) Calibrators cleared by the FDA?
CRP (II) Calibrators (K030546) received a 510(k) decision of Substantially Equivalent on June 2, 2003, 102 days after the submission was received.
What is the product code of K030546?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.