Helix Diagnostics, Inc.: FDA clearances and approvals
Helix Diagnostics, Inc. has 15 FDA 510(k) clearances (first 1991, latest 2000), across 6 product codes in 1 review panel. Median 510(k) review time: 81 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 6 | 6 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 3 | 3 |
| LKJ | Antinuclear Antibody, Antigen, Control | 2 | 2 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 2 | 2 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 1 | 1 |
| LKP | Anti-Sm Antibody, Antigen And Control | 1 | 1 |
Review panels
- Immunology (15)
Most recent Helix Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001900 | ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST | LRM | 2000-09-11 | 81 |
| K000489 | ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TEST | LLL | 2000-04-05 | 51 |
| K980337 | DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM | LJM | 1998-05-12 | 104 |
| K960091 | ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT | LRM | 1996-03-20 | 69 |
| K954723 | ENZYME IMMUNOASSAY ANA SCREENING TEST KIT | LKJ | 1995-12-15 | 63 |
| K954700 | ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT | LKJ | 1995-12-15 | 64 |
| K952253 | ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT | LLL | 1995-08-24 | 101 |
| K951850 | ENZYME IMMUNOASSAY ANTI-JO-1 ANTIBODY TEST KIT | LJM | 1995-07-18 | 88 |
| K951798 | ENZYME IMMUNOASSAY ANTI-SCI-70 ANTIBODY TEST KIT | LJM | 1995-07-17 | 90 |
| K940588 | ENZYME IMMUNOASSAY ANTI-SM/RNP ANTIBODY TEST KIT | LKO | 1994-04-20 | 71 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Helix Diagnostics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Helix Diagnostics, Inc. have?
Helix Diagnostics, Inc. has 15 FDA 510(k) clearances (first 1991, latest 2000), across 6 product codes in 1 review panel.
How long does FDA take to clear Helix Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Helix Diagnostics, Inc.'s cleared 510(k)s is 81 days.
What devices does Helix Diagnostics, Inc. make?
Its most frequent FDA product codes are LLL (Extractable Antinuclear Antibody, Antigen And Control, 6); LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, 3); LKJ (Antinuclear Antibody, Antigen, Control, 2).
Has Helix Diagnostics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Helix Diagnostics, Inc. Related entities may recall under other names.
Next steps
- See all 15 Helix Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLL, Helix Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.