The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Boehringer Mannheim Igg Assay.
Device ID | K955906 |
510k Number | K955906 |
Device Name: | BOEHRINGER MANNHEIM IGG ASSAY |
Classification | Igg (gamma Chain Specific), Antigen, Antiserum, Control |
Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
Contact | Johjn D Stevens |
Correspondent | Johjn D Stevens BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
Product Code | DFZ |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-29 |
Decision Date | 1996-02-09 |