The following data is part of a premarket notification filed by Grifols Usa, Llc with the FDA for Interlab Ife Test Using G 26 Ver. 2.0 Instrument.
| Device ID | K120169 |
| 510k Number | K120169 |
| Device Name: | INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT |
| Classification | Immunoelectrophoretic, Immunoglobulins, (g, A, M) |
| Applicant | GRIFOLS USA, LLC 482 CHERRY LANE RD. East Stroudsburg, PA 18301 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus GRIFOLS USA, LLC 482 CHERRY LANE RD. 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 | 2012-01-19 |
| Decision Date | 2012-08-24 |
| Summary: | summary |