The following data is part of a premarket notification filed by Beckman-diagnostic Systems Group with the FDA for I.d.-zone Immunofixation Electrophoresis Controls.
| Device ID | K945522 |
| 510k Number | K945522 |
| Device Name: | I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS |
| Classification | Igm, Antigen, Antiserum, Control |
| Applicant | BECKMAN-DIAGNOSTIC SYSTEMS GROUP 200 S. KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92821 -6208 |
| Contact | Don W Hart |
| Correspondent | Don W Hart BECKMAN-DIAGNOSTIC SYSTEMS GROUP 200 S. KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92821 -6208 |
| Product Code | DFT |
| Subsequent Product Code | DEH |
| Subsequent Product Code | DFH |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-10 |
| Decision Date | 1994-12-12 |