510(k) K131217
K131217 is an FDA 510(k) premarket notification submitted by Hitachi Chemical Diagnostics, Inc. for the device "S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN". The FDA issued a decision of Substantially Equivalent on June 7, 2013. The device falls under product code CIG (Diazo Colorimetry, Bilirubin), a Class II device regulated under 21 CFR 862.1110. Hitachi Chemical Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 7, 2013
- Date Received
- April 30, 2013
- 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