The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Lyme Igm Microassay.
| Device ID | K911330 |
| 510k Number | K911330 |
| Device Name: | LYME IGM MICROASSAY |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Contact | Tsue-ming Lin |
| Correspondent | Tsue-ming Lin 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 | 1991-03-25 |
| Decision Date | 1991-06-10 |