21 C.F.R. § 866.2440 Automated medium dispensing and stacking device.
Title 21 - Food and Drugs
(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). 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. The device is also exempt from the good manufacturing practice regulations in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files. [47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38791, July 25, 2001]
Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart C—Microbiology Devices
§ 866.2440 Automated medium dispensing and stacking device.
