FDA device listing
Clinitek Atlas Pro 12 Reagent Pak
FDA device listing 1544720357 · SIEMENS HEALTHCARE DIAGNOSTICS INC.
Key facts
| Proprietary names | Clinitek Atlas Pro 12 Reagent Pak |
|---|---|
| Owner/operator | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/operator number | 9096044 |
| Premarket submissions | K021428 |
| Product codes | CDM, CEN, JFY, JIL, JIN, JIP, JIR, JJB, JMT, JRE, KQO, LJX |
| Device names | CDM - Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.), CEN - Dye-Indicator, Ph (Urinary, Non-Quantitative), JFY - Enzymatic Method, Creatinine, JIL - Method, Enzymatic, Glucose (Urinary, Non-Quantitative), JIN - Nitroprusside, Ketones (Urinary, Non-Quant.), JIP - Blood, Occult, Enzymatic Method, In Urine, JIR - Indicator Method, Protein Or Albumin (Urinary, Non-Quant.), JJB - Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.), JMT - Diazo (Colorimetric), Nitrite (Urinary, Non-Quant), JRE - Refractometer For Clinical Use, KQO - Automated Urinalysis System, LJX - Test, Urine Leukocyte |
| Device class | Class I, Class II |
| Classification regulations (21 CFR) | 862.1115, 862.1225, 862.1340, 862.1435, 862.1510, 862.1550, 862.1645, 862.1785, 862.2800, 862.2900, 864.6550, 864.7675 |
| Review panels | Clinical Chemistry, Hematology |
| Registered establishments | Siemens Healthcare Diagnostics Inc, Siemens Healthcare Diagnostics, Inc. |
| Establishment registrations | 3002637618, 3009448641 |
| FEI numbers | 3002637618, 3009448641 |
| Establishment operations | Complaint File Establishment, Specification Developer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database