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 |