The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Anti-sm Microassay.
| Device ID | K894894 |
| 510k Number | K894894 |
| Device Name: | ANTI-SM MICROASSAY |
| Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
| Applicant | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Contact | David J Kiefer,phd |
| Correspondent | David J Kiefer,phd DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
| Product Code | LJM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-01 |
| Decision Date | 1989-08-24 |