Id-Fish Technology, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Id-Fish Technology, Inc.” (first 2024, latest 2025), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 288 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 |
|---|---|---|
| 2024 | 1 | 315 |
| 2025 | 1 | 262 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Id-Fish Technology, Inc. took a median 288 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | 2 | 2 |
| PYN | Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp. | 1 | 0 |
Review panels
- Microbiology (3)
Most recent Id-Fish Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242872 | iDart Lyme IgM ImmunoBlot Kit | LSR | 2025-06-12 | 262 |
| K233367 | iDart Lyme IgG ImmunoBlot Kit | LSR | 2024-08-12 | 315 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN160025 | De Novo | Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp. | 2017-08-18 |
Recalls
openFDA lists no recalls under a recalling firm named Id-Fish Technology, 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 Id-Fish Technology, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Id-Fish Technology, Inc.” (first 2024, latest 2025), plus 1 De Novo decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Id-Fish Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Id-Fish Technology, Inc. is 288 days.
Which FDA product codes appear under Id-Fish Technology, Inc.?
The most frequent FDA product codes under this applicant name are LSR (Reagent, Borrelia Serological Reagent, 2); PYN (Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp., 1).
Next steps
- See all 2 Id-Fish Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LSR, Id-Fish Technology, 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.