The following data is part of a premarket notification filed by Helix Diagnostics, Inc. with the FDA for Enzyme Immunoassay Ena Plus Screening Test Kit.
Device ID | K952253 |
510k Number | K952253 |
Device Name: | ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT |
Classification | Extractable Antinuclear Antibody, Antigen And Control |
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 | LLL |
CFR Regulation Number | 866.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-15 |
Decision Date | 1995-08-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847817022388 | K952253 | 000 |
00847817006944 | K952253 | 000 |