Calibrator 1,2, and 3 Models: GEN-CAL1, GEN-CAL2, and GEN-CAL3
FDA 510(k) K090283 · Genchem, Inc.
510(k) numberK090283
Submission
- Device name
- Calibrator 1,2, and 3 Models: GEN-CAL1, GEN-CAL2, and GEN-CAL3
- Applicant
- Genchem, Inc.
Brea, CA, US - Received
- February 5, 2009
- Decision date
- June 5, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K123321 | Dimension Chemistry III CalibratoryJIX · Traditional | Siemens Healthcare Diagnostics | 02/15/2013SE |
| K123372 | Abbott Lipid Multi Constituent CalibratorJIX · Traditional | Abbott Laboratories | 01/14/2013SE |
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Questions and answers
When was Calibrator 1,2, and 3 Models: GEN-CAL1, GEN-CAL2, and GEN-CAL3 cleared by the FDA?
Calibrator 1,2, and 3 Models: GEN-CAL1, GEN-CAL2, and GEN-CAL3 (K090283) received a 510(k) decision of Substantially Equivalent on June 5, 2009, 120 days after the submission was received.
What is the product code of K090283?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.