[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.3875]

[Page 226]
 
                        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. 864.3875  Automated tissue processor.

    (a) Identification. An automated tissue processor is an automated 
system used to process tissue specimens for examination through 
fixation, dehydration, and infiltration.
    (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 Sec. 864.9.

[45 FR 60591, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 
66 FR 38789, July 25, 2001]