Roche Cobas Amplicor Analyzer
FDA 510(k) K964506 · Roche Molecular Systems, Inc.
510(k) numberK964506
Submission
- Device name
- Roche Cobas Amplicor Analyzer
- Applicant
- Roche Molecular Systems, Inc.
Branchburg, NJ, US - Received
- November 8, 1996
- Decision date
- May 21, 1997
- 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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| K993634 | Careside AnalyzerJJF · Traditional | Careside, Inc. | 12/02/1999SE |
| K973628 | Vitalab Flexor/Vitalab Selectra 2/VITALAB VivaJJF · Traditional | Vital Scientific N.V. | 03/13/1998SE |
| K980056 | Careside AnalyzerJJF · Traditional | Exigent Diagnostics, Inc. | 03/06/1998SE |
| 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 Amplicor Analyzer cleared by the FDA?
Roche Cobas Amplicor Analyzer (K964506) received a 510(k) decision of Substantially Equivalent on May 21, 1997, 194 days after the submission was received.
What is the product code of K964506?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.