510(k) K040174
K040174 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corp. for the device "BILIRUBIN ASSAY ON THE OMNI S ANALYZER". The FDA issued a decision of Substantially Equivalent on May 14, 2004. The device falls under product code MQM (Bilirubin (Total And Unbound) In The Neonate Test System), a Class I device regulated under 21 CFR 862.1113. Roche Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2004
- Date Received
- January 26, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bilirubin (Total And Unbound) In The Neonate Test System
- Device Class
- Class I
- Regulation Number
- 862.1113
- Review Panel
- CH
- Submission Type