The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Cmv Igm Microassay.
| Device ID | K871832 |
| 510k Number | K871832 |
| Device Name: | CMV IGM MICROASSAY |
| Classification | Antibody Igm,if, Cytomegalovirus Virus |
| Applicant | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Contact | Kiefer, Phd |
| Correspondent | Kiefer, Phd DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Product Code | LKQ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-11 |
| Decision Date | 1987-08-07 |