TC Matrix Clinical Chemistry Analyzer
FDA 510(k) K073370 · Teco Diagnostics
510(k) numberK073370
Submission
- Device name
- TC Matrix Clinical Chemistry Analyzer
- Applicant
- Teco Diagnostics
Anaheim, CA, US - Received
- November 30, 2007
- Decision date
- May 8, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2160
- Specialty
- Clinical Chemistry
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Questions and answers
When was TC Matrix Clinical Chemistry Analyzer cleared by the FDA?
TC Matrix Clinical Chemistry Analyzer (K073370) received a 510(k) decision of Substantially Equivalent on May 8, 2008, 160 days after the submission was received.
What is the product code of K073370?
The FDA product code is JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2160.