The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Immage Immunochemistry System Ferritin (fer)reagent, Immage Immunochemistry System Ferritin Calibrator.
| Device ID | K983340 |
| 510k Number | K983340 |
| Device Name: | IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Contact | Richard T Ross |
| Correspondent | Richard T Ross BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-23 |
| Decision Date | 1998-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590223373 | K983340 | 000 |
| 15099590223243 | K983340 | 000 |