510(k) K905602
K905602 is an FDA 510(k) premarket notification submitted by Biotope, Inc. for the device "ECLIPSE ICA BUN". The FDA issued a decision of Substantially Equivalent on January 16, 1991. The device falls under product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Biotope, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 1991
- Date Received
- December 13, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Urease And Glutamic Dehydrogenase, Urea Nitrogen
- Device Class
- Class II
- Regulation Number
- 862.1770
- Review Panel
- CH
- Submission Type