The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Anti-dna Microassay.
Device ID | K912020 |
510k Number | K912020 |
Device Name: | ANTI-DNA MICROASSAY |
Classification | Anti-dna Antibody (enzyme-labeled), Antigen, Control |
Applicant | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
Contact | David J Kiefer |
Correspondent | David J Kiefer DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
Product Code | LRM |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-07 |
Decision Date | 1991-09-23 |