Cobas Integra Ceruloplasmin
FDA 510(k) K062379 · Roche Diagnostics Corp.
510(k) numberK062379
Submission
- Device name
- Cobas Integra Ceruloplasmin
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- August 15, 2006
- Decision date
- January 31, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
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| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 01/16/2015SE |
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | Randox Laboratories Limited | 12/08/2014SE |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
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Questions and answers
When was Cobas Integra Ceruloplasmin cleared by the FDA?
Cobas Integra Ceruloplasmin (K062379) received a 510(k) decision of Substantially Equivalent on January 31, 2007, 169 days after the submission was received.
What is the product code of K062379?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.