Roche Cobas Taqman Analyzer
FDA 510(k) K012966 · Roche Molecular Systems, Inc.
510(k) numberK012966
Submission
- Device name
- Roche Cobas Taqman Analyzer
- Applicant
- Roche Molecular Systems, Inc.
Pleasanton, CA, US - Received
- September 4, 2001
- Decision date
- February 1, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJF – Analyzer, Chemistry, Micro, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2170
- Specialty
- Clinical Chemistry
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| K973628 | Vitalab Flexor/Vitalab Selectra 2/VITALAB VivaJJF · Traditional | Vital Scientific N.V. | 03/13/1998SE |
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| K973177 | Mago Automated Eia ProcessorJJF · Traditional | Diamedix Corp. | 10/09/1997SE |
| K971491 | Synermed Ir 200 Chemistry AnalyzerJJF · Traditional | Synermed, Inc. | 06/26/1997SE |
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Questions and answers
When was Roche Cobas Taqman Analyzer cleared by the FDA?
Roche Cobas Taqman Analyzer (K012966) received a 510(k) decision of Substantially Equivalent on February 1, 2002, 150 days after the submission was received.
What is the product code of K012966?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.