510(k) K853357
K853357 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "URIC ACID REAGENT". The FDA issued a decision of Substantially Equivalent on Aug 19, 1985. The device falls under product code KNK (Acid, Uric, Uricase (Colorimetric)), a Class I device regulated under 21 CFR 862.1775. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 19, 1985
- Date Received
- Aug 12, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Acid, Uric, Uricase (Colorimetric)
- Device Class
- Class I
- Regulation Number
- 862.1775
- Review Panel
- CH
- Submission Type
- 510(k) Exempt