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 |