The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Na Alpha 1 Microglobulin Kit.
| Device ID | K904254 |
| 510k Number | K904254 |
| Device Name: | NA ALPHA 1 MICROGLOBULIN KIT |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Contact | John Hughes |
| Correspondent | John Hughes BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-14 |
| Decision Date | 1991-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768012938 | K904254 | 000 |