Product Code: KPB
FDA class 1
21 CFR 864.2360
Media And Components, Mycoplasma Detection
Hematology
This device comprises media and components used in laboratory settings for the detection of mycoplasma contamination in cell cultures or biological products. It is classified as FDA Class 1, the lowest risk level, subject to general controls only. The product code is KPB, regulated under 21 CFR 864.2360, and is reviewed under the Pathology panel despite being categorized within the Hematology specialty. No special flags apply.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
1
Research product code KPB in seconds
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Basic Information
- Product Code
- KPB
- Device Class
- FDA class 1
- Regulation Number
- 864.2360
- Medical Specialty
- Hematology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K781875 | STAIN KIT FOR CELL CULTURES (30-100-00) | Dec 20, 1978 | Substantially Equivalent | Flow Laboratories, Inc. |
| K781874 | MYCOPLASMA ARGININI FITC (30-403-41) | Dec 20, 1978 | Substantially Equivalent | Flow Laboratories, Inc. |
| K781390 | MYCOPLASMA HYORHINIS (BTS-7) | Sep 01, 1978 | Substantially Equivalent | Flow Laboratories, Inc. |
| K771867 | MYCOPLASMA DETECTION KIT | Nov 17, 1977 | Substantially Equivalent | Bioassay Systems Research Corp. |