Gonotec Calibration Solution 300 Mosmol/Kg for Osmometer
FDA 510(k) K032608 · Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB
510(k) numberK032608
Submission
- Device name
- Gonotec Calibration Solution 300 Mosmol/Kg for Osmometer
- Applicant
- Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB
Berlin, DE - Received
- August 25, 2003
- Decision date
- October 21, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
| 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 |
| K030546 | CRP (II) CalibratorsJIS · Traditional | Denka Seiken Co., Ltd. | 06/02/2003SE |
| 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 |
Questions and answers
When was Gonotec Calibration Solution 300 Mosmol/Kg for Osmometer cleared by the FDA?
Gonotec Calibration Solution 300 Mosmol/Kg for Osmometer (K032608) received a 510(k) decision of Substantially Equivalent on October 21, 2003, 57 days after the submission was received.
What is the product code of K032608?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.