510(k) K994438
K994438 is an FDA 510(k) premarket notification submitted by Spectrx, Inc. for the device "BILICHEK NON-INVASIVE BILIRUBIN ANALYZER". The FDA issued a decision of Substantially Equivalent on February 4, 2000. 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. Spectrx, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2000
- Date Received
- December 30, 1999
- 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