The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Anti-jo-1 Microassay.
| Device ID | K911679 |
| 510k Number | K911679 |
| Device Name: | ANTI-JO-1 MICROASSAY |
| Classification | Extractable Antinuclear Antibody, Antigen And 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 | LLL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-15 |
| Decision Date | 1991-09-23 |