510(k) K032860
K032860 is an FDA 510(k) premarket notification submitted by Immco Diagnostics, Inc. for the device "IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)". The FDA issued a decision of Substantially Equivalent on March 18, 2004. The device falls under product code NBT (Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)), a Class II device regulated under 21 CFR 866.5785. Immco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2004
- Date Received
- September 12, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
- Device Class
- Class II
- Regulation Number
- 866.5785
- Review Panel
- IM
- Submission Type