Matrix Plus(Tm) Chemistry Reference Standard
FDA 510(k) K901113 · Verichem Laboratories, Inc.
510(k) numberK901113
Submission
- Device name
- Matrix Plus(Tm) Chemistry Reference Standard
- Applicant
- Verichem Laboratories, Inc.
East Providence, RI, US - Received
- March 7, 1990
- Decision date
- March 29, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Wako Chemicals USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K112834 | Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit…JIX · Abbreviated | 03/28/2012SE |
| K974290 | Microprotein Standard KitJIX · Traditional | 12/19/1997SE |
| K973345 | Matrix Plus Multi-Calibrator KitJIX · Traditional | 10/29/1997SE |
| K972333 | Ammonia/Iron Standard KitJIX · Traditional | 07/23/1997SE |
| K924904 | Hdl-Cholesterol Standard, ModificationJIS · Traditional | 01/13/1993SE |
| K912513 | Electrolyte ControlJJR · Traditional | 07/19/1991SE |
| K882059 | Bilirubin StandardJIT · Traditional | 10/25/1988SE |
| K881320 | Urine Toxicology StandardDKB · Traditional | 09/09/1988SE |
| K875285 | Multi-Chemistry Linearity StandardJIX · Traditional | 09/02/1988SE |
| K882117 | Ethyl Alcohol StandardDNN · Traditional | 08/04/1988SE |
Questions and answers
When was Matrix Plus(Tm) Chemistry Reference Standard cleared by the FDA?
Matrix Plus(Tm) Chemistry Reference Standard (K901113) received a 510(k) decision of Substantially Equivalent on March 29, 1990, 22 days after the submission was received.
What is the product code of K901113?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.