510(k) K843673
K843673 is an FDA 510(k) premarket notification submitted by Institute Virion , Ltd. for the device "RESPIRATORY SYNCYTIAL VIRUS". The FDA issued a decision of Substantially Equivalent on September 26, 1985. The device falls under product code GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus), a Class I device regulated under 21 CFR 866.3480. 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 Controls), Respiratory Syncytial Virus
- Device Class
- Class I
- Regulation Number
- 866.3480
- Review Panel
- MI
- Submission Type