The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Immage Systems Total Immunoglobulin E (ige) Reagent Immage Ige Calibrator.
| Device ID | K024210 |
| 510k Number | K024210 |
| Device Name: | IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-20 |
| Decision Date | 2003-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590227029 | K024210 | 000 |