The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Immage Systems Low Concentration Immunoglobulin A Reagent.
| Device ID | K060130 |
| 510k Number | K060130 |
| Device Name: | IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT |
| Classification | Iga, 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 | CZP |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-18 |
| Decision Date | 2006-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590221225 | K060130 | 000 |