The following data is part of a premarket notification filed by Coulter Corp. with the FDA for Coulter Beta-2 Microglobulin Immunoassay.
| Device ID | K923421 |
| 510k Number | K923421 |
| Device Name: | COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | COULTER CORP. 600 COULTER WAY Hialeah, FL 33010 |
| Contact | Marion S Gaide |
| Correspondent | Marion S Gaide COULTER CORP. 600 COULTER WAY Hialeah, FL 33010 |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-13 |
| Decision Date | 1992-09-23 |