Stanbio Laboratory Sirrus Clinical Chemistry Analyzer
FDA 510(k) K042169 · Stanbio Laboratory
510(k) numberK042169
Submission
- Device name
- Stanbio Laboratory Sirrus Clinical Chemistry Analyzer
- Applicant
- Stanbio Laboratory
Boerne, TX, US - Received
- August 11, 2004
- Decision date
- March 14, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 Stanbio Laboratory Sirrus Clinical Chemistry Analyzer cleared by the FDA?
Stanbio Laboratory Sirrus Clinical Chemistry Analyzer (K042169) received a 510(k) decision of Substantially Equivalent on March 14, 2005, 215 days after the submission was received.
What is the product code of K042169?
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.