510(k) K922432
K922432 is an FDA 510(k) premarket notification submitted by New Horizons Diagnostics Co. for the device "CHOLERASCREEN". The FDA issued a decision of Substantially Equivalent on Dec 7, 1992. The device falls under product code GSQ (Antiserum, Vibrio Cholerae, All Varieties), a Class II device regulated under 21 CFR 866.3930. New Horizons Diagnostics Co. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 7, 1992
- Date Received
- May 22, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antiserum, Vibrio Cholerae, All Varieties
- Device Class
- Class II
- Regulation Number
- 866.3930
- Review Panel
- MI
- Submission Type