510(k) K946048
K946048 is an FDA 510(k) premarket notification submitted by Clinical Controls, Inc. for the device "LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2". The FDA issued a decision of Substantially Equivalent on Feb 10, 1995. The device falls under product code JZG (System, Test, Beta-2-Microglobulin Immunological), a Class II device regulated under 21 CFR 866.5630. Clinical Controls, Inc. has 17 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 10, 1995
- Date Received
- Dec 12, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Test, Beta-2-Microglobulin Immunological
- Device Class
- Class II
- Regulation Number
- 866.5630
- Review Panel
- IM
- Submission Type
- 510(k) Exempt