510(k) K864981
K864981 is an FDA 510(k) premarket notification submitted by Virion (U.S.), Inc. for the device "TOXOPLASMA GONDII". The FDA issued a decision of Substantially Equivalent on October 30, 1987. The device falls under product code GMN (Antigens, Cf, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Virion (U.S.), Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 1987
- Date Received
- December 22, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigens, Cf, Toxoplasma Gondii
- Device Class
- Class II
- Regulation Number
- 866.3780
- Review Panel
- MI
- Submission Type