The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Measles Igg Microassay.
| Device ID | K903961 |
| 510k Number | K903961 |
| Device Name: | MEASLES IGG MICROASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg |
| Applicant | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Contact | David Kiefer |
| Correspondent | David Kiefer DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Product Code | LJB |
| CFR Regulation Number | 866.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-28 |
| Decision Date | 1990-12-28 |