Disease Detection International, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Disease Detection International, Inc.” (first 1988, latest 1994), across 10 product codes in 2 review panels. Median 510(k) review time under this name: 112 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 6 | 6 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 3 | 3 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | 2 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | 2 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 1 | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
| LYF | Pneumocystis Carinii | 1 | 1 |
Review panels
- Microbiology (12)
- Clinical Chemistry (8)
Most recent Disease Detection International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K943252 | PRO-STEP LH OVULATION PREDICTION TEST | CEP | 1994-10-25 | 111 |
| K925303 | PRO-STEP PT HCG | JHI | 1993-06-15 | 237 |
| K925125 | PRO-STEP HCG | JHI | 1993-01-13 | 92 |
| K911826 | IMMUNOCARD HCG ONE STEP (I-S) TEST KIT | JHI | 1991-07-19 | 86 |
| K902571 | MODIFICATION OF SEROCARD RUBELLA IGG TEST | LFX | 1990-09-05 | 90 |
| K903070 | SEROCARD HSV IGG ANTIBODY TEST KIT | LGC | 1990-08-09 | 28 |
| K895912 | IMMUNOCARD HCG II-S TEST KIT | JHI | 1989-12-01 | 52 |
| K896109 | IMMUNOCARD STREP A TEST | GTZ | 1989-11-29 | 37 |
| K884249 | MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT | LGD | 1989-04-10 | 181 |
| K884248 | MODIFIED DDI SEROCARD CMV IGG TEST KIT | LFZ | 1989-04-10 | 181 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Disease Detection International, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Disease Detection International, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Disease Detection International, Inc.” (first 1988, latest 1994), across 10 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 Disease Detection International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Disease Detection International, Inc. is 112 days.
Which FDA product codes appear under Disease Detection International, Inc.?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 6); LFX (Enzyme Linked Immunoabsorbent Assay, Rubella, 3); LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus, 2).
Next steps
- See all 20 Disease Detection International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHI, Disease Detection International, Inc.'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.