The following data is part of a premarket notification filed by Grifols with the FDA for Immunofixation Electrophoresis Test Using Interlab G26 Instrument.
| Device ID | K103757 |
| 510k Number | K103757 |
| Device Name: | IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT |
| Classification | Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| Applicant | GRIFOLS 150 CHERRY LANE ROAD East Stroudsburg, PA 18301 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus GRIFOLS 150 CHERRY LANE ROAD East Stroudsburg, PA 18301 |
| Product Code | CFF |
| Subsequent Product Code | CEF |
| Subsequent Product Code | DEH |
| Subsequent Product Code | DFH |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-23 |
| Decision Date | 2011-10-13 |