Tago, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Tago, Inc.” (first 1983, latest 1984), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 37 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 |
|---|---|---|---|
| MSJ | Apolipoproteins | 2 | 2 |
| DAD | Haptoglobin, Antigen, Antiserum, Control | 1 | 1 |
| DCN | System, Test, C-Reactive Protein | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 1 | 1 |
| KTN | System, Test, Infectious Mononucleosis | 1 | 1 |
| LKL | Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control | 1 | 1 |
Review panels
- Immunology (4)
- Clinical Chemistry (3)
- Microbiology (1)
Most recent Tago, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841734 | TAGO FIFFU-GEN, OROSOMUCOID | LKL | 1984-06-01 | 36 |
| K841265 | TAGO DIFFU-GEN C-REACTIVE PROTEIN | DCN | 1984-05-22 | 57 |
| K834218 | DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - | MSJ | 1984-05-11 | 155 |
| K840404 | DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO | DAD | 1984-03-09 | 38 |
| K833129 | TAGO DIFFU-GEN-APOLIPOPROTEIN B-100 | MSJ | 1983-11-21 | 69 |
| K830611 | RA SCREENING TEST | DHR | 1983-03-24 | 24 |
| K830531 | MONO SCREENING TEST | KTN | 1983-03-17 | 27 |
| K830156 | HCG SCREENING TEST | JHJ | 1983-02-09 | 22 |
Recalls
openFDA lists no recalls under a recalling firm named Tago, 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 Tago, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Tago, Inc.” (first 1983, latest 1984), across 7 product codes in 3 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 Tago, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tago, Inc. is 37 days.
Which FDA product codes appear under Tago, Inc.?
The most frequent FDA product codes under this applicant name are MSJ (Apolipoproteins, 2); DAD (Haptoglobin, Antigen, Antiserum, Control, 1); DCN (System, Test, C-Reactive Protein, 1).
Next steps
- See all 8 Tago, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MSJ, Tago, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.