(a) Identification.
         A microtiter diluting and dispensing device is a mechanical device intended for medical purposes to dispense or serially dilute very small quantities of biological or chemical reagents for use in various diagnostic procedures.
     
    
        
        (b) Classification.
         Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of  part 807 of this chapter subject to the limitations in  § 866.9.
     
    
        
            Code of Federal Regulations
        
        [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 FR 38791, July 25, 2001]