510(k) K843613
K843613 is an FDA 510(k) premarket notification submitted by Immuno-Products Industries for the device "FLUORESCENT TREPONEMEL ANTIBODY-ABSORB". The FDA issued a decision of Substantially Equivalent on October 31, 1984. The device falls under product code GMS (Anti-Human Globulin, Fta-Abs Test), a Class II device regulated under 21 CFR 866.3830. Immuno-Products Industries has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1984
- Date Received
- September 10, 1984
- 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