510(k) K981766
K981766 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "URIC ACID". The FDA issued a decision of Substantially Equivalent on June 19, 1998. The device falls under product code CDO (Acid, Uric, Uricase (U.V.)), a Class I device regulated under 21 CFR 862.1775. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 1998
- Date Received
- May 19, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Uric, Uricase (U.V.)
- Device Class
- Class I
- Regulation Number
- 862.1775
- Review Panel
- CH
- Submission Type