The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Ez Complement C4.
Device ID | K892129 |
510k Number | K892129 |
Device Name: | EZ COMPLEMENT C4 |
Classification | Complement C4, Antigen, Antiserum, Control |
Applicant | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
Contact | David J Kiefer,ph.d |
Correspondent | David J Kiefer,ph.d DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
Product Code | DBI |
CFR Regulation Number | 866.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-27 |
Decision Date | 1989-04-14 |