510(k) K802276
K802276 is an FDA 510(k) premarket notification submitted by Bioware Products for the device "FTA-ABS BIOPAK". The FDA issued a decision of Substantially Equivalent on October 23, 1980. The device falls under product code JWL (Antigen, Treponema Pallidum For Fta-Abs Test), a Class II device regulated under 21 CFR 866.3830. Bioware Products has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 1980
- Date Received
- September 18, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Treponema Pallidum For Fta-Abs Test
- Device Class
- Class II
- Regulation Number
- 866.3830
- Review Panel
- MI
- Submission Type