510(k) K852506
K852506 is an FDA 510(k) premarket notification submitted by Solohill Engineering, Inc. for the device "BIOGLAS MICROCARRIER BEAD". The FDA issued a decision of Substantially Equivalent on July 12, 1985. The device falls under product code KJB (Apparatus, Roller), a Class I device regulated under 21 CFR 864.2240.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 1985
- Date Received
- June 12, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Roller
- Device Class
- Class I
- Regulation Number
- 864.2240
- Review Panel
- PA
- Submission Type