FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MYCOPLASMA DETECTION KIT
K Number: K771867
·
Decision Nov 17, 1977
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
3
Review Days
45
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MYCOPLASMA DETECTION KIT
- K Number
- K771867
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.2360
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Bioassay Systems Research Corp.
- Date Received
- October 3, 1977
- Decision Date
- November 17, 1977
- Product Code
- KPB
- Advisory Committee
- Hematology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPB | Media And Components, Mycoplasma Detection | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPB), ordered by most recent decision date.
MYCOPLASMA ARGININI FITC (30-403-41)
FDA 510(k)
FDA Class 1
·Hematology
STAIN KIT FOR CELL CULTURES (30-100-00)
FDA 510(k)
FDA Class 1
·Hematology
MYCOPLASMA HYORHINIS (BTS-7)
FDA 510(k)
FDA Class 1
·Hematology