Cliniqa Corporation: FDA filings under this applicant name
FDA lists 36 510(k) clearances under the applicant name “Cliniqa Corporation” (first 2001, latest 2013), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 34 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 | 1 | 24 |
| 2013 | 1 | 431 |
| 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) | 22 | 22 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 8 | 8 |
| JIX | Calibrator, Multi-Analyte Mixture | 2 | 2 |
| GGN | Plasma, Coagulation Control | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 | 1 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 | 1 |
Review panels
- Clinical Chemistry (35)
- Hematology (1)
Most recent Cliniqa Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120900 | I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 | GGN | 2013-05-31 | 431 |
| K121237 | BETA HCG CONTROL LEVEL 1 BETA HCG CONTROL LEVEL 2 BETA HCG CONTROL LEVEL 3 BETA HCG CALIBRATION VERIFICATION CONTROLS LE | JJX | 2012-05-18 | 24 |
| K083554 | CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 | JJY | 2009-04-21 | 141 |
| K081908 | CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2 | JJW | 2009-01-16 | 197 |
| K082107 | CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 | JJY | 2008-09-17 | 54 |
| K080973 | CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC | JJY | 2008-06-02 | 59 |
| K070741 | CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3 | JJY | 2007-05-04 | 49 |
| K062916 | CLINIQA LIQUID QC CARDIAC MARKER CONTROL SP, LEVELS 1,2, &3 | JJY | 2006-10-23 | 25 |
| K061182 | CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS;QALIB | JJY | 2006-05-25 | 28 |
| K060322 | CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED | JIT | 2006-03-21 | 40 |
26 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cliniqa Corporation.
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 Cliniqa Corporation?
FDA lists 36 510(k) clearances under the applicant name “Cliniqa Corporation” (first 2001, latest 2013), across 7 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 Cliniqa Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cliniqa Corporation is 34 days.
Which FDA product codes appear under Cliniqa Corporation?
The most frequent FDA product codes under this applicant name are JJY (Multi-Analyte Controls, All Kinds (Assayed), 22); JJX (Single (Specified) Analyte Controls (Assayed And Unassayed), 8); JIX (Calibrator, Multi-Analyte Mixture, 2).
Next steps
- See all 36 Cliniqa Corporation clearances with predicates and recalls
- Run predicate analysis for product code JJY, Cliniqa Corporation'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.