| Proprietary Name: |
Chemiluminescent Substrate Module; IML 2000 3rd Gen TSH; IML 2000 AlaTOP; IML 2000 FSH; IML 2000 Phenobarbital; IML 2000 Rubella Quant IgG; IML 2000 Theophylline; IML 2000 Toxoplasma Quant IgG; IML 2500 3rd Gen TSH; IML 2500 AlaTOP; IML 2500 FSH; IML 2500 Phenobarbital; IML 2500 Rubella Quant IgG; IML 2500 Theoplylline; IML 2500 Toxoplasma Quant IgG; IMMULITE 2000 Chemiluminescent Substrate Module; IMMULITE 2000 Immunoassay System; IMMULITE 2000 System; IMMULITE 2000 Systems Allergen Tube Caps; IMMULITE 2000 Systems Allergen Tubes; IMMULITE 2000 Systems Diluent Tube Caps; IMMULITE 2000 Systems Diluent Tubes; IMMULITE 2000 Systems Microsampling Tube Caps; IMMULITE 2000 Systems Microsampling Tubes; IMMULITE 2000 Systems Reaction Tubes; IMMULITE 2000 XPi Immunoassay System; IMMULITE 2000 XPi Nesting Cups 1mL; IMMULITE 2000 XPi Nesting Cups 2mL; Probe Cleaning Kit; Probe Wash; Sample Management System/VersaCell; VersaCell X3 Solution |
| 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: |
K970227 |
| Owner/Operator: |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Owner/Operator Number: |
9096044
|
| Establishment Operations: |
Manufacturer; Specification Developer
|
