510(k) K923859
K923859 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "PREMIER BLASTOMYCES". The FDA issued a decision of Substantially Equivalent on October 5, 1992. The device falls under product code MJL (Eia, Blastomyces Dermatitidis), a Class II device regulated under 21 CFR 866.3060. Meridian Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 5, 1992
- Date Received
- July 31, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Eia, Blastomyces Dermatitidis
- Device Class
- Class II
- Regulation Number
- 866.3060
- Review Panel
- MI
- Submission Type