Device Classification Name |
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
|
510(k) Number |
K181683 |
Device Name |
BD MAX CT/GC/TV 20-Day QC Panel |
Applicant |
Microbiologics, Inc. |
200 Cooper Avenue North |
St. Cloud,
MN
56303
|
|
Applicant Contact |
Tina Sobania |
Correspondent |
Microbiologics, Inc. |
200 Cooper Avenue North |
St. Cloud,
MN
56303
|
|
Correspondent Contact |
Tina Sobania |
Regulation Number | 866.3920
|
Classification Product Code |
|
Date Received | 06/26/2018 |
Decision Date | 08/28/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|