KIQ · Kit, Culture, Chromosome
Hematology · 21 CFR 864.2260 · Class 1
Overview
| Product Code | KIQ |
|---|---|
| Device Name | Kit, Culture, Chromosome |
| Regulation | 21 CFR 864.2260 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
A chromosome culture kit is a device containing the necessary ingredients (e.g., Minimum Essential Media (MEM) of McCoy's 5A culture media, phytohemagglutinin, fetal calf serum, antibiotics, and heparin) used to culture tissues for diagnosis of congenital chromosome abnormalities.
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 § 864.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K790239 | PHYTOHAEMAGGLUTININ | Pharmacia Fine Chemicals | Mar 8, 1979 | SESE |
Top Applicants
- Pharmacia Fine Chemicals — 1 clearance
