510(k) K843654
K843654 is an FDA 510(k) premarket notification submitted by Institute Virion , Ltd. for the device "CHLAMYDIA". The FDA issued a decision of Substantially Equivalent on August 8, 1985. The device falls under product code GPW (Antigen, Cf, Psittacosis (Chlamydia Group)), a Class I device regulated under 21 CFR 866.3120. Institute Virion , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 1985
- Date Received
- September 17, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Cf, Psittacosis (Chlamydia Group)
- Device Class
- Class I
- Regulation Number
- 866.3120
- Review Panel
- MI
- Submission Type