Datapro Clinical Chelistry Analyzer
FDA 510(k) K042767 · Thermo Electron Corporation
510(k) numberK042767
Submission
- Device name
- Datapro Clinical Chelistry Analyzer
- Applicant
- Thermo Electron Corporation
Louisville, CO, US - Received
- October 5, 2004
- Decision date
- April 27, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFR – Hexokinase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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Questions and answers
When was Datapro Clinical Chelistry Analyzer cleared by the FDA?
Datapro Clinical Chelistry Analyzer (K042767) received a 510(k) decision of Substantially Equivalent on April 27, 2005, 204 days after the submission was received.
What is the product code of K042767?
The FDA product code is CFR – Hexokinase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.