510(k) K802933
K802933 is an FDA 510(k) premarket notification submitted by Orion Diagnostica, Inc. for the device "MUMPS S & V ANTIGENS & CONTROLS". The FDA issued a decision of Substantially Equivalent on December 31, 1980. The device falls under product code GRC (Antigen, Cf (Including Cf Control), Mumps Virus), a Class I device regulated under 21 CFR 866.3380. Orion Diagnostica, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 31, 1980
- Date Received
- November 19, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Cf (Including Cf Control), Mumps Virus
- Device Class
- Class I
- Regulation Number
- 866.3380
- Review Panel
- MI
- Submission Type