The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Dart Immunoglobulins Reagent System.
| Device ID | K851541 |
| 510k Number | K851541 |
| Device Name: | DART IMMUNOGLOBULINS REAGENT SYSTEM |
| Classification | Igg, Antigen, Antiserum, Control |
| Applicant | COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
| Contact | Richardson-jones |
| Correspondent | Richardson-jones COULTER ELECTRONICS, INC. 440 WEST 20 ST. Hialeah, FL 33010 |
| Product Code | DEW |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-16 |
| Decision Date | 1985-07-15 |