510(k) K943466
K943466 is an FDA 510(k) premarket notification submitted by Cambridge Diagnostic Products, Inc. for the device "MINI S.F.T. (URINE PRESERVATIVE)". The FDA issued a decision of Substantially Equivalent on May 24, 1995. The device falls under product code LXG (Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use), a Class I device regulated under 21 CFR 862.2050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 1995
- Date Received
- June 15, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type