FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THERMOSTABLE NUCLEASE TEST AGAR
K Number: K864454
·
Decision Nov 28, 1986
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
145
Applicant Total
3
Review Days
16
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
- THERMOSTABLE NUCLEASE TEST AGAR
- K Number
- K864454
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Dimed, Intl.
- Date Received
- November 12, 1986
- Decision Date
- November 28, 1986
- Product Code
- JSH
- Advisory Committee
- Microbiology
- 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 |
|---|---|---|---|
| JSH | Culture Media, Non-Selective And Differential | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSH), ordered by most recent decision date.
FLO AGAR
FDA 510(k)
FDA Class 1
·Microbiology
UREA AGAR BASE
FDA 510(k)
FDA Class 1
·Microbiology
UREA BROTH
FDA 510(k)
FDA Class 1
·Microbiology
DNASE TEST AGAR
FDA 510(k)
FDA Class 1
·Microbiology
RUSSELL DOUBLE SUGAR AGAR
FDA 510(k)
FDA Class 1
·Microbiology
PHENOL RED BROTH BASE
FDA 510(k)
FDA Class 1
·Microbiology