510(k) K931350
K931350 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL TEST URIC ACID". The FDA issued a decision of Substantially Equivalent on October 1, 1993. The device falls under product code KNK (Acid, Uric, Uricase (Colorimetric)), a Class I device regulated under 21 CFR 862.1775. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 1993
- Date Received
- March 17, 1993
- 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