510(k) K791571
K791571 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "TOXOPLASMA ANTIBODY TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on September 24, 1979. The device falls under product code GLZ (Antigens, If, Toxoplasma Gondii), a Class II device regulated under 21 CFR 866.3780. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 1979
- Date Received
- August 13, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigens, If, Toxoplasma Gondii
- Device Class
- Class II
- Regulation Number
- 866.3780
- Review Panel
- MI
- Submission Type