510(k) K936252
K936252 is an FDA 510(k) premarket notification submitted by Light Diagnostics for the device "COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY". The FDA issued a decision of Substantially Equivalent on September 8, 1995. The device falls under product code GNM (Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6), a Class I device regulated under 21 CFR 866.3145. Light Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 1995
- Date Received
- December 30, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
- Device Class
- Class I
- Regulation Number
- 866.3145
- Review Panel
- MI
- Submission Type