510(k) K853681
K853681 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "SIGMA 610 FOR PROTEIN IN URINE & CSF". The FDA issued a decision of Substantially Equivalent on Oct 28, 1985. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 28, 1985
- Date Received
- Sep 4, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Biuret (Colorimetric), Total Protein
- Device Class
- Class II
- Regulation Number
- 862.1635
- Review Panel
- CH
- Submission Type
- 510(k) Exempt