862.1150—Calibrator.
               		
               	 	
               	 	
               	 	               	 	               	 	               	 	               	 	
               	 	
    
        
        (a) Identification.
         A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also  § 862.2 in this part.)
     
    
        
        (b) Classification.
         Class II.