510(k) K842749
K842749 is an FDA 510(k) premarket notification submitted by Intl. Diagnostic Technology for the device "FIAX TOTAL IGE TEST KIT". The FDA issued a decision of Substantially Equivalent on August 28, 1984. The device falls under product code DGP (Ige, Fitc, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Intl. Diagnostic Technology has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 1984
- Date Received
- July 13, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ige, Fitc, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5510
- Review Panel
- IM
- Submission Type