The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Rubella Igm Microassay.
| Device ID | K883778 |
| 510k Number | K883778 |
| Device Name: | RUBELLA IGM MICROASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| 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 | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-06 |
| Decision Date | 1988-10-25 |