London Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “London Diagnostics, Inc.” (first 1988, latest 1991), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 45 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 |
|---|---|---|---|
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 2 | 2 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 | 1 |
| CFL | Radioimmunoassay, Human Growth Hormone | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| DBF | Ferritin, Antigen, Antiserum, Control | 1 | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
Plus 1 more product codes.
Review panels
- Clinical Chemistry (10)
- Immunology (2)
Most recent London Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K914835 | LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY | CEC | 1991-12-17 | 53 |
| K911985 | LUMATAG T4 CHEMILUMINESCENCE ASSAY | CDX | 1991-08-02 | 88 |
| K912858 | LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY | CFL | 1991-07-30 | 32 |
| K905814 | LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY | CGJ | 1991-02-04 | 38 |
| K904458 | LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION | CFT | 1990-10-12 | 11 |
| K903130 | LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY | CEW | 1990-09-25 | 70 |
| K903195 | LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY | DGC | 1990-08-02 | 14 |
| K902443 | LUMATAG(TM) LH DIAGNOSTIC KIT | CEP | 1990-08-02 | 62 |
| K901484 | LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC | JHI | 1990-05-01 | 33 |
| K901075 | LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET. | DBF | 1990-04-02 | 25 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named London Diagnostics, 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.
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.
- London Intl., LLC (6 510(k)s)
- London International Group, Inc. (5 510(k)s)
- London International U.S. Holdings, Inc. (2 510(k)s)
- London Rubber Co. (India) , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under London Diagnostics, Inc.?
FDA lists 12 510(k) clearances under the applicant name “London Diagnostics, Inc.” (first 1988, latest 1991), across 11 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 London Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name London Diagnostics, Inc. is 45 days.
Which FDA product codes appear under London Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are CFT (Radioimmunoassay, Prolactin (Lactogen), 2); CDX (Radioimmunoassay, Total Thyroxine, 1); CEC (Radioimmunoassay, Free Thyroxine, 1).
Next steps
- See all 12 London Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CFT, London Diagnostics, 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.