FDA Device Registration & Listing · Carolina, PR, US · Registration 3010324880
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| GKZ | Counter, Differential Cell | Hematology | Class 2 | 864.5220 | 2024-03-25 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | Clinical Chemistry | Class 2 | 862.1690 | 2024-03-25 |
| JIO | Blood, Occult, Colorimetric, In Urine | Hematology | Class 2 | 864.6550 | 2021-07-22 |
| LJX | Test, Urine Leukocyte | Hematology | Class 1 | 864.7675 | 2021-07-22 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | Clinical Chemistry | Class 1 | 862.1550 | 2021-07-22 |
| JJB | Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | Clinical Chemistry | Class 1 | 862.1115 | 2021-07-22 |
| CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | Clinical Chemistry | Class 1 | 862.1785 | 2021-07-22 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Clinical Chemistry | Class 1 | 862.1510 | 2021-07-22 |
| KQO | Automated Urinalysis System | Clinical Chemistry | Class 1 | 862.2900 | 2021-07-22 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Clinical Chemistry | Class 1 | 862.1645 | 2021-07-22 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | Clinical Chemistry | Class 1 | 862.1435 | 2021-07-22 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | Clinical Chemistry | Class 2 | 862.1340 | 2021-07-22 |
| KQO | Automated Urinalysis System | Clinical Chemistry | Class 1 | 862.2900 | 2021-07-22 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | Clinical Chemistry | Class 1 | 862.1510 | 2021-07-22 |
| JIO | Blood, Occult, Colorimetric, In Urine | Hematology | Class 2 | 864.6550 | 2021-07-22 |
| JRE | Refractometer For Clinical Use | Clinical Chemistry | Class 1 | 862.2800 | 2021-07-22 |
| JIN | Nitroprusside, Ketones (Urinary, Non-Quant.) | Clinical Chemistry | Class 1 | 862.1435 | 2021-07-22 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | Clinical Chemistry | Class 1 | 862.2300 | 2021-07-22 |
| JMA | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | Clinical Chemistry | Class 1 | 862.1095 | 2021-07-22 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | Clinical Chemistry | Class 1 | 862.1645 | 2021-07-22 |
| LJX | Test, Urine Leukocyte | Hematology | Class 1 | 864.7675 | 2021-07-22 |
| CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | Clinical Chemistry | Class 1 | 862.1785 | 2021-07-22 |
| CEN | Dye-Indicator, Ph (Urinary, Non-Quantitative) | Clinical Chemistry | Class 1 | 862.1550 | 2021-07-22 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | Clinical Chemistry | Class 2 | 862.1340 | 2021-07-22 |
| MRG | System, Test, Vitamin D | Clinical Chemistry | Class 2 | 862.1825 | 2024-03-25 |
| PPM | General Purpose Reagent | Pathology | Class 1 | 864.4010 | 2025-03-21 |
| CFR | Hexokinase, Glucose | Clinical Chemistry | Class 2 | 862.1345 | 2021-07-22 |
| JIX | Calibrator, Multi-Analyte Mixture | Clinical Chemistry | Class 2 | 862.1150 | 2021-07-22 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Clinical Chemistry | Class 1 | 862.2160 | 2021-07-22 |
| CEM | Electrode, Ion Specific, Potassium | Clinical Chemistry | Class 2 | 862.1600 | 2021-07-22 |
| CGZ | Electrode, Ion-Specific, Chloride | Clinical Chemistry | Class 2 | 862.1170 | 2021-07-22 |
| JGS | Electrode, Ion Specific, Sodium | Clinical Chemistry | Class 2 | 862.1665 | 2021-07-22 |
| KQO | Automated Urinalysis System | Clinical Chemistry | Class 1 | 862.2900 | 2025-04-11 |
| KHO | Fluorometer, For Clinical Use | Clinical Chemistry | Class 1 | 862.2560 | 2024-03-25 |
| LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | Immunology | Class 2 | 866.6010 | 2024-03-25 |
| CEC | Radioimmunoassay, Free Thyroxine | Clinical Chemistry | Class 2 | 862.1695 | 2024-03-25 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K910283 | Danam Electronics | DANAM DATACELL-18 | 1991-04-12 |
| K102064 | Becton, Dickinson & CO | BD FACS SAMPLE PREP ASSISTANT III (SPA III) | 2011-03-07 |
| K850376 | Terumo Medical Corp. | TERUMO SENSIBEAD EIA TSH KIT | 1985-03-04 |
| K843395 | Hybritech, Inc. | ENCORE TSH REAGENT | 1984-10-11 |
| K854087 | Organon Teknika Corp. | NML TSH IRMA | 1985-10-25 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0002-05 | ABX Diagnostics Inc | 2 | Automated Differential Cell Counter |
| Z-0003-05 | ABX Diagnostics Inc | 2 | Automated Differential Cell Counter |
| Z-0011-2014 | Siemens Healthcare Diagnostics | 2 | ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter)
The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts. |
| Z-0021-2013 | Beckman Coulter Inc. | 2 | Unicel DxH 800 Coulter Cellular Analysis System, Part Number 629029.
The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: " Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood. " Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial) (BF). |
| Z-0033-2013 | Beckman Coulter Inc. | 2 | CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013.
Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3+/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/ CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3009297077 | Diatron MI Plc | Budapest, HU |
| 3027394506 | Becton, Dickinson and Company, BD Biosciences | Milpitas, CA, US |
| 2182501 | R & D SYSTEMS, INC. | MINNEAPOLIS, MN, US |
| 9613959 | SYSMEX CORPORATION TECHNO PARK | KOBE Hyogo, JP |
| 3002759288 | SYSMEX CORPORATION KAKOGAWA FACTORY | Kakogawa Hyogo, JP |
3010324880 when referencing this establishment in official correspondence.