510(k) K033187
K033187 is an FDA 510(k) premarket notification submitted by Interlab S.R.L. for the device "INTERLAB IMMUNOFIXATION TEST(S)". The FDA issued a decision of Substantially Equivalent on November 19, 2003. The device falls under product code CFF (Immunoelectrophoretic, Immunoglobulins, (G, A, M)), a Class II device regulated under 21 CFR 866.5510. Interlab S.R.L. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 2003
- Date Received
- October 1, 2003
- 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