Bilirubin Assay on the Omni S Analyzer
FDA 510(k) K040174 · Roche Diagnostics Corp.
510(k) numberK040174
Submission
- Device name
- Bilirubin Assay on the Omni S Analyzer
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- January 26, 2004
- Decision date
- May 14, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQM – Bilirubin (Total And Unbound) In The Neonate Test System
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1113
- Specialty
- Clinical Chemistry
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Questions and answers
When was Bilirubin Assay on the Omni S Analyzer cleared by the FDA?
Bilirubin Assay on the Omni S Analyzer (K040174) received a 510(k) decision of Substantially Equivalent on May 14, 2004, 109 days after the submission was received.
What is the product code of K040174?
The FDA product code is MQM – Bilirubin (Total And Unbound) In The Neonate Test System, a Class I (low risk) device regulated under 21 CFR 862.1113.