Compur Easy Touch Chemistry Analyzer-
FDA 510(k) K831227 · Worthington Diagnostic Systems
510(k) numberK831227
Submission
- Device name
- Compur Easy Touch Chemistry Analyzer-
- Applicant
- Worthington Diagnostic Systems
Mchenry, IL, US - Received
- April 15, 1983
- Decision date
- June 2, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Synermed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K833708 | Compur* M1000 Hemoglobin & ErythrocyteLKZ · Traditional | 01/04/1984SE |
| K832785 | Compur* Easy Touch Uric Acid ReagentKNK · Traditional | 10/14/1983SE |
| K832749 | Easytouch Bun Reagent SetCDQ · Traditional | 10/14/1983SE |
| K832748 | Compur* Easytouch Total BilirubinCIG · Traditional | 10/14/1983SE |
| K832427 | Easytouch Tromboplastin ReagentGJS · Traditional | 10/14/1983SE |
| K832750 | Easytouch Hemoglobin ReagentKHG · Traditional | 09/26/1983SE |
| K832426 | Easytouch Triglycerides Reagent SetCDT · Traditional | 09/12/1983SE |
| K831477 | Demand Analyzer SystemJJE · Traditional | 06/17/1983SE |
| K831318 | Compur* M1100 Hematrcrit SystemJPI · Traditional | 06/08/1983SE |
| K831103 | Tia-Igm Reagent & Calibrator SetsDFT · Traditional | 04/27/1983SE |
Questions and answers
When was Compur Easy Touch Chemistry Analyzer- cleared by the FDA?
Compur Easy Touch Chemistry Analyzer- (K831227) received a 510(k) decision of Substantially Equivalent on June 2, 1983, 48 days after the submission was received.
What is the product code of K831227?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.