510(k) K120946
K120946 is an FDA 510(k) premarket notification submitted by Immuno-Mycologics, Inc. for the device "ALPHA CRYPTOCOCCAL ANTIGEN EIA". The FDA issued a decision of Substantially Equivalent on December 17, 2012. The device falls under product code MDU (Antigen, Elisa, Cryptococcus), a Class II device regulated under 21 CFR 866.3165. Immuno-Mycologics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2012
- Date Received
- March 29, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Elisa, Cryptococcus
- Device Class
- Class II
- Regulation Number
- 866.3165
- Review Panel
- MI
- Submission Type