FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SELECTIVE CULTURE MEDIUM
K Number: K840971
·
Decision Apr 13, 1984
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
25
Applicant Total
3
Review Days
38
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
- SELECTIVE CULTURE MEDIUM
- K Number
- K840971
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2360
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Chatham Biological
- Date Received
- March 6, 1984
- Decision Date
- April 13, 1984
- Product Code
- JSD
- 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 |
|---|---|---|---|
| JSD | Culture Media, Selective Broth | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSD), ordered by most recent decision date.
FASTIDIOUS INOCULUM BROTH
FDA 510(k)
FDA Class 1
·Microbiology
CAMPY BROTH
FDA 510(k)
FDA Class 1
·Microbiology
SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331
FDA 510(k)
FDA Class 1
·Microbiology
BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802
FDA 510(k)
FDA Class 1
·Microbiology
ALKALINE PEPTONE WATER
FDA 510(k)
FDA Class 1
·Microbiology
TODD HEWITT W/CNA (LIM BROTH)
FDA 510(k)
FDA Class 1
·Microbiology