Alko Diagnostic Corp.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Alko Diagnostic Corp.” (first 1982, latest 2000), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 78 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 |
|---|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 21 | 21 |
| CGZ | Electrode, Ion-Specific, Chloride | 2 | 2 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 2 | 2 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 1 | 1 |
| JFP | Electrode, Ion Specific, Calcium | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 1 | 1 |
| JPK | Mixture, Hematology Quality Control | 1 | 1 |
| JZX | Equipment, Rocket Immunoelectrophoresis | 1 | 1 |
Review panels
- Clinical Chemistry (27)
- Hematology (3)
- Immunology (1)
Most recent Alko Diagnostic Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001484 | CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 | JIX | 2000-06-19 | 39 |
| K982501 | ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 | JIX | 1998-09-01 | 43 |
| K972004 | ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS | CGZ | 1997-06-16 | 17 |
| K970921 | STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) | JIX | 1997-04-08 | 27 |
| K962864 | THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS | KRZ | 1996-12-18 | 148 |
| K963734 | ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS | CGZ | 1996-10-24 | 56 |
| K960085 | ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS | JIX | 1996-03-11 | 60 |
| K955154 | CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT | JIX | 1995-12-11 | 28 |
| K951071 | ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS | KRZ | 1995-07-24 | 138 |
| K950902 | ALKO TONOMETERED SALINE CONTROL | JJS | 1995-03-30 | 30 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Alko Diagnostic Corp..
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.
- Alko Scientific Co. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alko Diagnostic Corp.?
FDA lists 31 510(k) clearances under the applicant name “Alko Diagnostic Corp.” (first 1982, latest 2000), across 9 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 Alko Diagnostic Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alko Diagnostic Corp. is 78 days.
Which FDA product codes appear under Alko Diagnostic Corp.?
The most frequent FDA product codes under this applicant name are JIX (Calibrator, Multi-Analyte Mixture, 21); CGZ (Electrode, Ion-Specific, Chloride, 2); KRZ (Calibrator For Hemoglobin And Hematocrit Measurement, 2).
Next steps
- See all 31 Alko Diagnostic Corp. clearances with predicates and recalls
- Run predicate analysis for product code JIX, Alko Diagnostic Corp.'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.