The following data is part of a premarket notification filed by Helix Diagnostics, Inc. with the FDA for Enzyme Immunoassay Ana Screening Test Kit.
| Device ID | K954723 |
| 510k Number | K954723 |
| Device Name: | ENZYME IMMUNOASSAY ANA SCREENING TEST KIT |
| Classification | Antinuclear Antibody, Antigen, 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 | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-13 |
| Decision Date | 1995-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847817022319 | K954723 | 000 |
| 03610520310618 | K954723 | 000 |
| 03610520547663 | K954723 | 000 |
| 03610520560457 | K954723 | 000 |
| 03610520569184 | K954723 | 000 |
| 05391516747493 | K954723 | 000 |
| 05391516746595 | K954723 | 000 |
| 05391516743914 | K954723 | 000 |
| 00847817006913 | K954723 | 000 |
| 00847817006982 | K954723 | 000 |
| 00847817006999 | K954723 | 000 |
| 00847817007019 | K954723 | 000 |
| 00847817007026 | K954723 | 000 |
| 00847817021688 | K954723 | 000 |
| 00840733101014 | K954723 | 000 |