510(k) K023599
K023599 is an FDA 510(k) premarket notification submitted by Meridian Bioscience, Inc. for the device "IMMUNOCARD STAT! E. COLI O157 PLUS". The FDA issued a decision of Substantially Equivalent on January 3, 2003. The device falls under product code GMZ (Antigens, All Types, Escherichia Coli), a Class I device regulated under 21 CFR 866.3255. Meridian Bioscience, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 2003
- Date Received
- October 28, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigens, All Types, Escherichia Coli
- Device Class
- Class I
- Regulation Number
- 866.3255
- Review Panel
- MI
- Submission Type