Ise Module and Bar Code Reader Addition for the Datapro Clinical Chemistry Analyzer
FDA 510(k) K070531 · Thermo Fisher Scientific
510(k) numberK070531
Submission
- Device name
- Ise Module and Bar Code Reader Addition for the Datapro Clinical Chemistry Analyzer
- Applicant
- Thermo Fisher Scientific
Pittsburgh, PA, US - Received
- February 23, 2007
- Decision date
- September 4, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGZ – Electrode, Ion-Specific, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
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Questions and answers
When was Ise Module and Bar Code Reader Addition for the Datapro Clinical Chemistry Analyzer cleared by the FDA?
Ise Module and Bar Code Reader Addition for the Datapro Clinical Chemistry Analyzer (K070531) received a 510(k) decision of Substantially Equivalent on September 4, 2007, 193 days after the submission was received.
What is the product code of K070531?
The FDA product code is CGZ – Electrode, Ion-Specific, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.