510(k) K781403
K781403 is an FDA 510(k) premarket notification submitted by Zeus Scientific, Inc. for the device "FTA-ABS TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on August 21, 1978. The device falls under product code GMS (Anti-Human Globulin, Fta-Abs Test), a Class II device regulated under 21 CFR 866.3830. Zeus Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1978
- Date Received
- August 15, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anti-Human Globulin, Fta-Abs Test
- Device Class
- Class II
- Regulation Number
- 866.3830
- Review Panel
- MI
- Submission Type