KPB · Media And Components, Mycoplasma Detection
Hematology · 21 CFR 864.2360 · Class 1
Overview
| Product Code | KPB |
|---|---|
| Device Name | Media And Components, Mycoplasma Detection |
| Regulation | 21 CFR 864.2360 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
Mycoplasma detection media and components are used to detect and isolate mycoplasma pleuropneumonia-like organisms (PPLO), a common microbial contaminant in cell cultures.
Classification Rationale
Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K781875 | STAIN KIT FOR CELL CULTURES (30-100-00) | Flow Laboratories, Inc. | Dec 20, 1978 | SESE |
| K781874 | MYCOPLASMA ARGININI FITC (30-403-41) | Flow Laboratories, Inc. | Dec 20, 1978 | SESE |
| K781390 | MYCOPLASMA HYORHINIS (BTS-7) | Flow Laboratories, Inc. | Sep 1, 1978 | SESE |
| K771867 | MYCOPLASMA DETECTION KIT | Bioassay Systems Research Corp. | Nov 17, 1977 | SESE |
Top Applicants
- Flow Laboratories, Inc. — 3 clearances
- Bioassay Systems Research Corp. — 1 clearance
