The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Vzv Microassay.
| Device ID | K890642 |
| 510k Number | K890642 |
| Device Name: | VZV MICROASSAY |
| Classification | Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
| 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 | LFY |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-08 |
| Decision Date | 1989-05-15 |