510(k) K964590
K964590 is an FDA 510(k) premarket notification submitted by Chromatics Color Sciences Intl., Inc. for the device "COLORMATE III". The FDA issued a decision of Substantially Equivalent on July 24, 1997. 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. Chromatics Color Sciences Intl., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 1997
- Date Received
- November 15, 1996
- 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