Shield Diagnostics, Ltd.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Shield Diagnostics, Ltd.” (first 1990, latest 2000), across 16 product codes in 4 review panels. Median 510(k) review time under this name: 68 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 3 | 3 |
| MID | System, Test, Anticardiolipin Immunological | 3 | 3 |
| JZO | System, Test, Thyroid Autoantibody | 2 | 2 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | 2 |
| LKJ | Antinuclear Antibody, Antigen, Control | 2 | 2 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 2 | 2 |
| LKP | Anti-Sm Antibody, Antigen And Control | 2 | 2 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | 2 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | 2 |
| DBL | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control | 1 | 1 |
Plus 6 more product codes.
Review panels
- Immunology (22)
- Hematology (3)
- Clinical Chemistry (1)
- Microbiology (1)
Most recent Shield Diagnostics, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000398 | SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 | GGP | 2000-04-17 | 70 |
| K982879 | SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY | MSV | 1998-10-15 | 62 |
| K980885 | SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY | GGP | 1998-08-21 | 165 |
| K972981 | SHIELD HELICO-G2 ELISA KIT | LYR | 1998-03-17 | 218 |
| K962825 | SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY | GGP | 1996-11-15 | 119 |
| K963525 | DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT | DBL | 1996-11-07 | 64 |
| K961515 | QUANTASE PHENYLALANINE ASSAY | JNB | 1996-06-12 | 63 |
| K955303 | DIASTAT ANTI-CARDIOLIPIN KIT | MID | 1996-05-30 | 192 |
| K952183 | DIASTAT ANTI-THYROGLOBULIN KIT | JZO | 1995-06-30 | 52 |
| K951487 | DIASTAT ANTI-THYROID PEROXIDASE KIT | JZO | 1995-06-30 | 91 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shield Diagnostics, Ltd..
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.
- Shield Gloves Manufacturer (M) Sdn Bhd (18 510(k)s)
- Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. (5 510(k)s)
- Shield Laboratories, Inc. (2 510(k)s)
- Shield Computers , Ltd. (1 510(k)s)
- Shield Gloves Medical Products Sdn Bhd (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shield Diagnostics, Ltd.?
FDA lists 27 510(k) clearances under the applicant name “Shield Diagnostics, Ltd.” (first 1990, latest 2000), across 16 product codes in 4 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 Shield Diagnostics, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shield Diagnostics, Ltd. is 68 days.
Which FDA product codes appear under Shield Diagnostics, Ltd.?
The most frequent FDA product codes under this applicant name are GGP (Test, Qualitative And Quantitative Factor Deficiency, 3); MID (System, Test, Anticardiolipin Immunological, 3); JZO (System, Test, Thyroid Autoantibody, 2).
Next steps
- See all 27 Shield Diagnostics, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GGP, Shield Diagnostics, Ltd.'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.