Orgentec: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Orgentec” (first 1995, latest 1996), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 181 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 4 | 4 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | 2 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 | 1 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 1 | 1 |
| LKP | Anti-Sm Antibody, Antigen And Control | 1 | 1 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 1 | 1 |
Review panels
- Immunology (9)
- Clinical Chemistry (1)
Most recent Orgentec 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954831 | ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY | LKO | 1996-05-08 | 201 |
| K954830 | ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY | LKP | 1996-05-08 | 201 |
| K954832 | ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY | LJM | 1996-04-18 | 181 |
| K954829 | ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAY | LJM | 1996-04-18 | 181 |
| K954815 | ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAY | LJM | 1996-04-18 | 182 |
| K954814 | ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAY | LJM | 1996-04-18 | 182 |
| K960274 | ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY | JIR | 1996-03-29 | 70 |
| K955134 | ORGENTEC ENASCREEN ELISA ASSAY | LLL | 1996-03-20 | 132 |
| K955133 | ORGENTEC ENASCREEN PIN IMMUNO ASSAY | LLL | 1996-03-20 | 132 |
| K953671 | ORGEN TEC ANTI-DSDNA ELISA ASSAY | LRM | 1995-11-09 | 94 |
Recalls
openFDA lists no recalls under a recalling firm named Orgentec.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Orgentec Diagnostika GmbH (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Orgentec?
FDA lists 10 510(k) clearances under the applicant name “Orgentec” (first 1995, latest 1996), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Orgentec?
The median time from FDA receipt to decision across 510(k)s cleared under the name Orgentec is 181 days.
Which FDA product codes appear under Orgentec?
The most frequent FDA product codes under this applicant name are LJM (Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, 4); LLL (Extractable Antinuclear Antibody, Antigen And Control, 2); JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.), 1).
Next steps
- See all 10 Orgentec clearances with predicates and recalls
- Run predicate analysis for product code LJM, Orgentec's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.