The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Ez Complement C1.
| Device ID | K891904 |
| 510k Number | K891904 |
| Device Name: | EZ COMPLEMENT C1 |
| Classification | Complement C3b Activator, 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 | DAC |
| CFR Regulation Number | 866.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-27 |
| Decision Date | 1989-04-14 |