510(k) K936089
K936089 is an FDA 510(k) premarket notification submitted by Chemicon Intl., Inc. for the device "COXSACKIE A24 VIRUS 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. Chemicon Intl., Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 1995
- Date Received
- December 21, 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