510(k) K840257
K840257 is an FDA 510(k) premarket notification submitted by Applied Polytechnology, Inc. for the device "RAPID IMMUNO-ASSAY SYS". The FDA issued a decision of Substantially Equivalent on April 19, 1984. The device falls under product code LLG (Kit, Igg, Platelet Associated), a Class II device regulated under 21 CFR 864.5425. Applied Polytechnology, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 1984
- Date Received
- January 23, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Igg, Platelet Associated
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type