KPB — Media And Components, Mycoplasma Detection Class I
FDA product code KPB covers "Media And Components, Mycoplasma Detection", a Class I medical device regulated under 21 CFR 864.2360. Submissions are reviewed by the Hematology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KPB
- Device Class
- Class I
- Regulation Number
- 864.2360
- Submission Type
- Review Panel
- PA
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K781875 | flow laboratories | STAIN KIT FOR CELL CULTURES (30-100-00) | December 20, 1978 |
| K781874 | flow laboratories | MYCOPLASMA ARGININI FITC (30-403-41) | December 20, 1978 |
| K781390 | flow laboratories | MYCOPLASMA HYORHINIS (BTS-7) | September 1, 1978 |
| K771867 | bioassay systems research | MYCOPLASMA DETECTION KIT | November 17, 1977 |