Device Classification Name |
test, hiv detection
|
510(k) Number |
BK230833 |
Tradenames |
Access HIV Ag/Ab combo,
Access HIV Ag/Ab combo Calibrators,
Access HIV Ag/Ab combo QC
|
Device Name |
Test, HIV Detection |
Original Applicant |
Beckman Coulter, Inc. |
1000 lake hazeltine dr |
chaska,
MN
55318
|
|
Regulation Number | 866.3956
|
Classification Product Code |
|
Date Received | 04/10/2023 |
Decision Date | 07/27/2023 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Microbiology
|
Review Advisory Committee |
Microbiology
|
Type |
510(k) Traditional
|
Total Product Life Cycle (TPLC) |
TPLC Device Report
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
Combination Product |
No
|
In Vitro Product |
Yes
|
|
|