The following data is part of a premarket notification filed by Bio-rad Laboratories with the FDA for Ana-screen With Mdss.
| Device ID | K113610 |
| 510k Number | K113610 |
| Device Name: | ANA-SCREEN WITH MDSS |
| Classification | Antinuclear Antibody, Antigen, Control |
| Applicant | Bio-Rad Laboratories BIOPLEX 2200 DIVISION 5500 EAST SECOND ST Benicia, CA 94510 |
| Contact | Juang Wang |
| Correspondent | Juang Wang Bio-Rad Laboratories BIOPLEX 2200 DIVISION 5500 EAST SECOND ST Benicia, CA 94510 |
| Product Code | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-06 |
| Decision Date | 2012-07-09 |
| Summary: | summary |