[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.3800]

[Page 235-236]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 864_HEMATOLOGY AND PATHOLOGY DEVICES--Table of Contents
 
           Subpart D_Pathology Instrumentation and Accessories
 
Sec. 864.3800  Automated slide stainer.

    (a) Identification. An automated slide stainer is a device used to 
stain histology, cytology, and hematology slides for diagnosis.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in

[[Page 236]]

subpart E of part 807 of this chapter subject to the limitations in 
Sec. 864.9.

[45 FR 60591, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 
66 FR 38789, July 25, 2001]