Los Alamos Diagnostics: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Los Alamos Diagnostics” (first 1987, latest 1989), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 41 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 4 | 4 |
| JXA | Kit, Screening, Urine | 3 | 3 |
Review panels
- Clinical Chemistry (4)
- Microbiology (3)
Most recent Los Alamos Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896117 | MODIFIED MODEL 535(TM) LUMINOMETER | JJQ | 1989-11-30 | 41 |
| K883385 | RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST | JXA | 1988-09-07 | 29 |
| K882608 | LAD MODEL 633 LUMINOMETER | JJQ | 1988-08-29 | 66 |
| K881439 | MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM | JXA | 1988-04-28 | 23 |
| K874262 | LAD MODEL 735 LUMINOMETER | JJQ | 1987-11-27 | 38 |
| K864202 | UTISCREEN(R) BACTERIAL ATP TEST | JXA | 1987-02-13 | 109 |
| K864201 | LAD MODEL 535 LUMINOMETER | JJQ | 1987-01-13 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Los Alamos Diagnostics.
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 Los Alamos Diagnostics?
FDA lists 7 510(k) clearances under the applicant name “Los Alamos Diagnostics” (first 1987, latest 1989), across 2 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 Los Alamos Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Los Alamos Diagnostics is 41 days.
Which FDA product codes appear under Los Alamos Diagnostics?
The most frequent FDA product codes under this applicant name are JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 4); JXA (Kit, Screening, Urine, 3).
Next steps
- See all 7 Los Alamos Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code JJQ, Los Alamos Diagnostics'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.