(a) Identification.
         A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.
     
    
        
        (b) Classification.
         Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of  part 807 of this chapter subject to the limitations in  § 864.9.
     
    
        
            Code of Federal Regulations
        
        [45 FR 60635, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]