510(k) K872197
K872197 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT". The FDA issued a decision of Substantially Equivalent on Aug 13, 1987. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 13, 1987
- Date Received
- Jun 8, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Diazo Colorimetry, Bilirubin
- Device Class
- Class II
- Regulation Number
- 862.1110
- Review Panel
- CH
- Submission Type
- 510(k)