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Clinical Chemistry devices
409 product codes reviewed by the Clinical Chemistry panel. 13,074 510(k) clearances and 3,481 recalls in the FDA data, 72% of those recalls name a 510(k).
71510(k)s in 12 months
180recalls in 12 months
2,491recalls that name a 510(k)
Active product codes, Class II
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 2 | 1 | 33 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 2 | 9 | 14 |
| QFG | Alternate Controller Enabled Insulin Infusion Pump | 2 | 6 | 14 |
| NBW | System, Test, Blood Glucose, Over The Counter | 2 | 6 | 4 |
| QJI | Interoperable Automated Glycemic Controller | 2 | 10 | 0 |
| QBJ | Integrated Continuous Glucose Monitoring System, Factory Calibrated | 2 | 3 | 5 |
| PZI | Prescription Use Blood Glucose Meter For Near-Patient Testing | 2 | 1 | 5 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | 1 | 4 |
| CEM | Electrode, Ion Specific, Potassium | 2 | 1 | 3 |
| NBC | Test, Natriuretic Peptide | 2 | 4 | 0 |
| PDJ | Hemoglobin A1c Test System | 2 | 2 | 2 |
| QLG | Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems | 2 | 0 | 4 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 2 | 2 | 1 |
| CKG | Radioimmunoassay, Acth | 2 | 0 | 3 |
| NHG | Enzyme Immunoassay, Cortisol, Salivary | 2 | 0 | 3 |
| NSU | Instrumentation For Clinical Multiplex Test Systems | 2 | 0 | 3 |
| QWZ | Prognostic Test For Assessment Of Chronic Kidney Disease Progression | 2 | 0 | 3 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 2 | 0 | 2 |
| MRG | System, Test, Vitamin D | 2 | 0 | 2 |
| QRX | Continuous Glucose Monitor Informed Insulin Dose Calculator | 2 | 2 | 0 |
| SBH | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter | 2 | 2 | 0 |
| CFR | Hexokinase, Glucose | 2 | 1 | 0 |
| CGA | Glucose Oxidase, Glucose | 2 | 1 | 0 |
| CGL | Electrode, Ion Based, Enzymatic, Creatinine | 2 | 1 | 0 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 2 | 0 | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 2 | 1 | 0 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 | 1 | 0 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 2 | 1 | 0 |
| JFY | Enzymatic Method, Creatinine | 2 | 1 | 0 |
| JGS | Electrode, Ion Specific, Sodium | 2 | 1 | 0 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 2 | 0 | 1 |
| JIT | Calibrator, Secondary | 2 | 0 | 1 |
| JIX | Calibrator, Multi-Analyte Mixture | 2 | 0 | 1 |
| JKR | Radioimmunoassay, Calcitonin | 2 | 1 | 0 |
| KHS | Enzymatic, Carbon-Dioxide | 2 | 0 | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 2 | 0 | 1 |
| KQP | Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase | 2 | 0 | 1 |
| LPT | System, Test, Urinary Methylmalonic Acid | 2 | 0 | 1 |
| MLM | Enzyme Immunoassay, Tracrolimus | 2 | 0 | 1 |
| MMI | Immunoassay Method, Troponin Subunit | 2 | 1 | 0 |
| OTA | Mass Spectrometer For Clinical Multiplex Test Systems | 2 | 0 | 1 |
| PIG | Acute Kidney Injury Test System | 2 | 0 | 1 |
| PQO | Anti-Müllerian Hormone Test System | 2 | 0 | 1 |
| QWH | Prognostic Test For Development Or Progression Of Preeclampsia | 2 | 0 | 1 |
| SAF | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter | 2 | 1 | 0 |
| SFU | Glucose Range Monitoring System | 2 | 1 | 0 |
| SHB | Creatinine Test System For At Home Prescription Use | 2 | 1 | 0 |
| SJD | Integrated Continuous Glucose Ketone Monitoring System | 2 | 1 | 0 |
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