510(k) K843662
K843662 is an FDA 510(k) premarket notification submitted by Institute Virion , Ltd. for the device "MEASLES VIRUS RUBEOLA". The FDA issued a decision of Substantially Equivalent on September 26, 1985. The device falls under product code GRJ (Antigen, Cf, (Including Cf Control), Rubeola), a Class I device regulated under 21 CFR 866.3520. Institute Virion , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 1985
- Date Received
- September 17, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Cf, (Including Cf Control), Rubeola
- Device Class
- Class I
- Regulation Number
- 866.3520
- Review Panel
- MI
- Submission Type