The following data is part of a premarket notification filed by Helix Diagnostics, Inc. with the FDA for Enzyme Immunoassay Anti-centromere Antibody Test.
Device ID | K000489 |
510k Number | K000489 |
Device Name: | ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST |
Classification | Extractable Antinuclear Antibody, Antigen And 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 | LLL |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-14 |
Decision Date | 2000-04-05 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847817022340 | K000489 | 000 |