Calcium, Azo Dye Reagent
FDA 510(k) K040972 · Genchem, Inc.
510(k) numberK040972
Submission
- Device name
- Calcium, Azo Dye Reagent
- Applicant
- Genchem, Inc.
Brea, CA, US - Received
- April 14, 2004
- Decision date
- December 27, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CJY – Azo Dye, Calcium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1145
- Specialty
- Clinical Chemistry
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| K151113 | ELITech Clinical Systems CALCIUM ARSENAZOCJY · Traditional | Elitechgroup | 07/22/2015SE |
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| K083386 | Advia Chemistry CALCIUM_2 (CA_2) Method, Models P/M 02189699 (40 ML Fill), P/N 02189915…CJY · Traditional | Siemens Healthcare Diagnostics | 04/02/2009SE |
| K072356 | S-Test CaCJY · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 06/24/2008SE |
| K073355 | Calcium, Scal, Nortrol, AbtrolCJY · Traditional | Thermofisher Scientific OY | 02/28/2008SE |
| K072443 | Vitros Chemistry Products Ca DT Slides and DT Calibrator Kit and Vitros Ca AssayCJY · Special | Ortho-Clinical Diagnostics, Inc. | 09/24/2007SE |
More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K090283 | Calibrator 1,2, and 3 Models: GEN-CAL1, GEN-CAL2, and GEN-CAL3JIX · Abbreviated | 06/05/2009SE |
| K040977 | Genchem Electrolyte BufferJGS · Traditional | 12/27/2004SE |
| K040976 | Genchem Creatinine ReagentCGX · Traditional | 12/27/2004SE |
| K040975 | Genchem CO2 Acid ReagentJFL · Traditional | 12/27/2004SE |
| K040974 | Glucose Oxidase, GlucoseCGA · Traditional | 12/27/2004SE |
| K040973 | Bun ReagentCDS · Traditional | 12/27/2004SE |
| K040971 | Genchem Ise Electrolyte ReferenceJGS · Traditional | 12/22/2004SE |
Questions and answers
When was Calcium, Azo Dye Reagent cleared by the FDA?
Calcium, Azo Dye Reagent (K040972) received a 510(k) decision of Substantially Equivalent on December 27, 2004, 257 days after the submission was received.
What is the product code of K040972?
The FDA product code is CJY – Azo Dye, Calcium, a Class II (moderate risk) device regulated under 21 CFR 862.1145.