510(k) K863287
K863287 is an FDA 510(k) premarket notification submitted by Catachem, Inc. for the device "URIC ACID (URICASE) METHOD-II". The FDA issued a decision of Substantially Equivalent on September 29, 1986. The device falls under product code JHC (Acid, Uric, Uricase (Oxygen Rate)), a Class I device regulated under 21 CFR 862.1775. Catachem, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1986
- Date Received
- August 25, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Uric, Uricase (Oxygen Rate)
- Device Class
- Class I
- Regulation Number
- 862.1775
- Review Panel
- CH
- Submission Type