The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Lyme Disease Microassay.
Device ID | K890843 |
510k Number | K890843 |
Device Name: | LYME DISEASE MICROASSAY |
Classification | Reagent, Borrelia Serological Reagent |
Applicant | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
Contact | Lin, Phd |
Correspondent | Lin, Phd DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
Product Code | LSR |
CFR Regulation Number | 866.3830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-21 |
Decision Date | 1989-07-25 |