510(k) K854173
K854173 is an FDA 510(k) premarket notification submitted by Baker Instructions Corp. for the device "UCD URINE SPECIMEN COLLECTOR". The FDA issued a decision of Substantially Equivalent on November 4, 1985. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Baker Instructions Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 1985
- Date Received
- October 15, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collector, Urine, (And Accessories) For Indwelling Catheter
- Device Class
- Class II
- Regulation Number
- 876.5250
- Review Panel
- GU
- Submission Type