[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR864.3010]

[Page 215]
 
                        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. 864.3010  Tissue processing equipment.


    (a) Identification. Tissue processing equipment consists of devices 
used to prepare human tissue specimens for diagnostic histological 
examination by processing specimens through the various stages of 
decalcifying, infiltrating, sectioning, and mounting on microscope 
slides.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. The 
device is also exempt from the current good manufacturing practice 
regulations in part 820 of this chapter, with the exception of 
Sec. 820.180, with respect to general requirements concerning records, 
and Sec. 820.198, with respect to complaint files.

[45 FR 60587, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989]