Device |
culture media, antimicrobial susceptibility test, mueller hinton agar/broth |
Regulation Description |
Culture medium for antimicrobial susceptibility tests. |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | JTZ |
Premarket Review |
Office of In Vitro Diagnostics and Radiological Health
(OIR)
|
Submission Type |
510(k)
|
Regulation Number |
866.1700
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Recognized Consensus Standards
|
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|