The following data is part of a premarket notification filed by Beckman Coulter, Inc with the FDA for Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman Coulter.
| Device ID | K130122 |
| 510k Number | K130122 |
| Device Name: | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | BECKMAN COULTER, INC 250 S. KRAEMER BLVD E1.SE. 01 Brea, CA 92821 |
| Contact | Amanda Brown |
| Correspondent | Amanda Brown BECKMAN COULTER, INC 250 S. KRAEMER BLVD E1.SE. 01 Brea, CA 92821 |
| Product Code | CFN |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-17 |
| Decision Date | 2014-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590227043 | K130122 | 000 |
| 15099590221218 | K130122 | 000 |