JTB · Device, Media Dispensing/Stacking
Microbiology · 21 CFR 866.2440 · Class 1
Overview
| Product Code | JTB |
|---|---|
| Device Name | Device, Media Dispensing/Stacking |
| Regulation | 21 CFR 866.2440 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| GMP Exempt | Yes |
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.
Classification Rationale
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 requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K802561 | HI VOLUME PUMPING CHAMBER | Acacia, Inc. | Oct 31, 1980 | SESE |
| K790514 | I NETILMICIN RIA KIT | Diagnostic Products Corp. | May 3, 1979 | SESE |
Top Applicants
- Acacia, Inc. — 1 clearance
- Diagnostic Products Corp. — 1 clearance
