510(k) K993213
K993213 is an FDA 510(k) premarket notification submitted by Kamiya Biomedical Co. for the device "K-ASSAY IGA". The FDA issued a decision of Substantially Equivalent on November 23, 1999. The device falls under product code CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M)), a Class II device regulated under 21 CFR 866.5510. Kamiya Biomedical Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 1999
- Date Received
- September 24, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoelectrophoretic, Immunoglobulins, (G, A, M)
- Device Class
- Class II
- Regulation Number
- 866.5510
- Review Panel
- IM
- Submission Type