510(k) K875320
K875320 is an FDA 510(k) premarket notification submitted by Biotrol, USA, Inc. for the device "BIOTROL URIC ACID ENZYMATIQUE UV H.P.". The FDA issued a decision of Substantially Equivalent on February 1, 1988. The device falls under product code CDO (Acid, Uric, Uricase (U.V.)), a Class I device regulated under 21 CFR 862.1775. Biotrol, USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1988
- Date Received
- December 29, 1987
- 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