Careside Analyzer
FDA 510(k) K993634 · Careside, Inc.
510(k) numberK993634
Submission
- Device name
- Careside Analyzer
- Applicant
- Careside, Inc.
Culver City, CA, US - Received
- October 27, 1999
- Decision date
- December 2, 1999
- 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
Other 510(k)s with product code JJF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K052794 | Eti-Max 3000JJF · Traditional | DiaSorin, Inc. | 03/31/2006SE |
| K040332 | Polymedco Spotchem Ez Chemistry AnalyzerJJF · Traditional | Arkray, Inc. | 06/16/2004SE |
| K033734 | Lightcycler Instrument Version 1.2JJF · Traditional | Roche Diagnostics Corp. | 12/17/2003SE |
| K013654 | Precision Systems Analette Chemistry AnalyzerJJF · Traditional | Precision Systems, Inc. | 06/05/2002SE |
| K012966 | Roche Cobas Taqman AnalyzerJJF · Traditional | Roche Molecular Systems, Inc. | 02/01/2002SE |
| 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 |
| K964506 | Roche Cobas Amplicor AnalyzerJJF · Traditional | Roche Molecular Systems, Inc. | 05/21/1997SE |
More from Roche Molecular Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K020484 | Careside LDHCFH · Traditional | 07/03/2002SE |
| K020486 | Careside GGTJPZ · Traditional | 07/01/2002SE |
| K020487 | Careside AltCKA · Traditional | 06/04/2002SE |
| K020488 | Careside TrglycerideCDT · Traditional | 04/15/2002SE |
| K002792 | Careside CholinesteraseDIH · Traditional | 11/08/2000SE |
| K001462 | Careside HemoglobinKHG · Traditional | 08/21/2000SE |
| K993771 | Careside Direct BilirubinCIG · Traditional | 12/27/1999SE |
| K992475 | Careside CO2, TotalKHS · Traditional | 09/15/1999SE |
| K991717 | Careside MGJGJ · Traditional | 08/10/1999SE |
| K991371 | Careside AmmoniaJID · Traditional | 08/03/1999SE |
Questions and answers
When was Careside Analyzer cleared by the FDA?
Careside Analyzer (K993634) received a 510(k) decision of Substantially Equivalent on December 2, 1999, 36 days after the submission was received.
What is the product code of K993634?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.