| Proprietary Name: |
Atellica CH 930 Analyzer; Atellica CH 930 Analyzer (Refurbished); Atellica CH Albumin BCP Calibrator (AlbP CAL); Atellica CH Check Reagent (CHK); Atellica CH Cleaner; Atellica CH Conditioner; Atellica CH Diluent; Atellica CH EMPTY; Atellica CH EMPTY1; Atellica CH EMPTY2; Atellica CH HA1c_E High Volume Bottles; Atellica CH HA1c_E High Volume Conversion Kit; Atellica CH HA1c_E High Volume Lables; Atellica CH IMT Diluent (IMT Diluent); Atellica CH IMT Dilution Check (IMT Dilution Check); Atellica CH IMT Standard A (IMT Standard A); Atellica CH IMT Standard B + Salt Bridge (IMT Standard B + Salt Bridge); Atellica CH Lamp Coolant (LC); Atellica CH Lid Keying Feature; Atellica CH Reagent Probe Cleaner 1 (RPC1); Atellica CH Reagent Probe Cleaner 2 (RPC2); Atellica CH Reagent Probe Cleaner 4 (RPC4); Atellica CH Wash; Atellica CH Water Bath Additive (WBA); Atellica Direct Load |
| Classification Name: |
ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Product Code: |
JJE |
| Device Class: |
1 |
| Regulation Number: |
862.2160 |
| Medical Specialty: |
Clinical Chemistry |
| Registered Establishment Name: |
Siemens Healthcare Diagnostics Inc.
|
| Registered Establishment Number: |
2247117
|
| Premarket Submission Number: |
K151767 |
| Owner/Operator: |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/Operator Number: |
9096044
|
| Establishment Operations: |
Manufacturer
|
