Glycated Protein Calibrators
FDA 510(k) K940008 · Primus Corp.
510(k) numberK940008
Submission
- Device name
- Glycated Protein Calibrators
- Applicant
- Primus Corp.
Kansas City, MO, US - Received
- January 4, 1994
- Decision date
- May 9, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIS – Calibrator, Primary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| 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 |
|---|---|---|
| K062658 | Primus A1CARE AssayLCP · Traditional | 11/26/2007SE |
| K013787 | Nycocard CRPDCK · Traditional | 05/14/2002SE |
| K014084 | Nycocard CRP ControlDCK · Traditional | 01/07/2002SE |
| K993131 | Nycocard HBA1C Glycosylated Hemoglobin AssayLCP · Traditional | 05/22/2000SE |
| K994045 | Primus Liquid Calibrator for GHB/A1C Level 1 and Level 2LCP · Special | 12/21/1999SE |
| K992921 | Primus Liquid Control for Ghb/Alc Level I and Level IILCP · Traditional | 11/12/1999SE |
| K955283 | Primus Variant System PVS99GKA · Traditional | 03/01/1996SE |
| K942009 | Primus Rapid Gel 100 Glycated Hemoglobin AssayLCP · Traditional | 09/14/1994SE |
| K940142 | Glycated Protein ControlsJJX · Traditional | 04/26/1994SE |
| K936204 | Glycated Hemoglobin CalibratorsLCP · Traditional | 03/22/1994SE |
Questions and answers
When was Glycated Protein Calibrators cleared by the FDA?
Glycated Protein Calibrators (K940008) received a 510(k) decision of Substantially Equivalent on May 9, 1994, 125 days after the submission was received.
What is the product code of K940008?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.