The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Auraflex B2-microglobulin.
Device ID | K944846 |
510k Number | K944846 |
Device Name: | AURAFLEX B2-MICROGLOBULIN |
Classification | System, Test, Beta-2-microglobulin Immunological |
Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
Contact | C D Kafader Ii |
Correspondent | C D Kafader Ii ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
Product Code | JZG |
CFR Regulation Number | 866.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-30 |
Decision Date | 1995-06-20 |