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 |