Vitalab Flexor/Vitalab Selectra 2/VITALAB Viva
FDA 510(k) K973628 · Vital Scientific N.V.
510(k) numberK973628
Submission
- Device name
- Vitalab Flexor/Vitalab Selectra 2/VITALAB Viva
- Applicant
- Vital Scientific N.V.
Newton, MA, US - Received
- September 24, 1997
- Decision date
- March 13, 1998
- 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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| K013654 | Precision Systems Analette Chemistry AnalyzerJJF · Traditional | Precision Systems, Inc. | 06/05/2002SE |
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| K993634 | Careside AnalyzerJJF · Traditional | Careside, Inc. | 12/02/1999SE |
| 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 |
| K964506 | Roche Cobas Amplicor AnalyzerJJF · Traditional | Roche Molecular Systems, Inc. | 05/21/1997SE |
More from Roche Molecular Systems, Inc.
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| K022021 | Vital Scientific Aptt, Aptt & Quikcoag ApttGFO · Traditional | 11/01/2002SE |
| K021976 | FIBRON-1, FIBRON-4, Quikcoag, FibronKQG · Traditional | 10/25/2002SE |
| K022046 | Vital Scientific Coagulation Control,Coagulation Control Level 1,2,3,QUIKCOAG…GGN · Traditional | 07/23/2002SE |
| K020840 | Vital Scientific PT with CalciumGJS · Traditional | 05/15/2002SE |
Questions and answers
When was Vitalab Flexor/Vitalab Selectra 2/VITALAB Viva cleared by the FDA?
Vitalab Flexor/Vitalab Selectra 2/VITALAB Viva (K973628) received a 510(k) decision of Substantially Equivalent on March 13, 1998, 170 days after the submission was received.
What is the product code of K973628?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.