510(k) K010052
K010052 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER". The FDA issued a decision of Substantially Equivalent on March 19, 2001. 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. Respironics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 2001
- Date Received
- January 8, 2001
- Clearance Type
- Abbreviated
- 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