510(k) K812500
K812500 is an FDA 510(k) premarket notification submitted by Harleco for the device "ULTRACHEM URIC ACID ALDH, ITEM #65047". The FDA issued a decision of Substantially Equivalent on September 23, 1981. The device falls under product code CDO (Acid, Uric, Uricase (U.V.)), a Class I device regulated under 21 CFR 862.1775. Harleco has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 1981
- Date Received
- August 31, 1981
- 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