The following data is part of a premarket notification filed by Helix Diagnostics, Inc. with the FDA for Enzyme Immunoassay Anti-sci-70 Antibody Test Kit.
Device ID | K951798 |
510k Number | K951798 |
Device Name: | ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT |
Classification | Antinuclear Antibody (enzyme-labeled), Antigen, Controls |
Applicant | HELIX DIAGNOSTICS, INC. 3148 INDUSTRIAL BLVD. West Sacramento, CA 95691 -6221 |
Contact | Virginia L Cappel |
Correspondent | Virginia L Cappel HELIX DIAGNOSTICS, INC. 3148 INDUSTRIAL BLVD. West Sacramento, CA 95691 -6221 |
Product Code | LJM |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-18 |
Decision Date | 1995-07-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847817022432 | K951798 | 000 |