The following data is part of a premarket notification filed by Helix Diagnostics, Inc. with the FDA for Enzyme Immunoassay Anti-ssdna Antibody Test.
| Device ID | K001900 |
| 510k Number | K001900 |
| Device Name: | ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST |
| Classification | Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Applicant | HELIX DIAGNOSTICS, INC. 3148 INDUSTRIAL BLVD. West Sacramento, CA 95691 -6221 |
| Contact | Virginia Cappel |
| Correspondent | Virginia Cappel HELIX DIAGNOSTICS, INC. 3148 INDUSTRIAL BLVD. West Sacramento, CA 95691 -6221 |
| Product Code | LRM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-22 |
| Decision Date | 2000-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817022463 | K001900 | 000 |