[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: 21CFR866.2440]

[Page 238]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES--Table of Contents
 
                     Subpart C--Microbiology Devices
 
Sec. 866.2440  Automated medium dispensing and stacking device.

    (a) Identification. An automated medium dispensing and stacking 
device is a device intended for medical purposes to dispense a 
microbiological culture medium into petri dishes and then mechanically 
stack the petri dishes.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807. This device also is exempt from the good manufacturing practice 
regulation in part 820, with the exception of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.