Casco Standards: FDA filings under this applicant name
FDA lists 38 510(k) clearances under the applicant name “Casco Standards” (first 1984, latest 1998), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 58 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 15 | 15 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 10 | 10 |
| JIX | Calibrator, Multi-Analyte Mixture | 4 | 4 |
| DIF | Drug Mixture Control Materials | 3 | 3 |
| JIT | Calibrator, Secondary | 3 | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| JJR | Electrolyte Controls (Assayed And Unassayed) | 1 | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 | 1 |
Review panels
Most recent Casco Standards 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981436 | DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109 | JIX | 1998-04-24 | 10 |
| K972904 | DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL | JJY | 1998-02-20 | 198 |
| K962629 | DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR | JIX | 1996-09-13 | 70 |
| K962630 | DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL | JJY | 1996-07-22 | 17 |
| K961750 | DOCUMENT CARDIAC ASSAYED CONTROL | JJY | 1996-07-22 | 77 |
| K960244 | DOCUMENT TDM ULTRA ASSAYED CONTROL | DIF | 1996-03-22 | 66 |
| K955155 | DOCUMENT TDM ULTRA UNASSAYED CONTROL | DIF | 1995-12-20 | 37 |
| K950469 | DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET | JJY | 1995-04-11 | 67 |
| K945718 | DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET | JJX | 1995-01-17 | 57 |
| K945315 | DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL | JJY | 1994-12-09 | 38 |
28 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Casco Standards.
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 Casco Standards?
FDA lists 38 510(k) clearances under the applicant name “Casco Standards” (first 1984, latest 1998), across 8 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 Casco Standards?
The median time from FDA receipt to decision across 510(k)s cleared under the name Casco Standards is 58 days.
Which FDA product codes appear under Casco Standards?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 15); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 10); JIX (Calibrator, Multi-Analyte Mixture, 4).
Next steps
- See all 38 Casco Standards clearances with predicates and recalls
- Run predicate analysis for product code JJY, Casco Standards'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.