Atlas FDA

Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

FDA 510(k) clearance DEN150058 · decided 2016-03-28

Clearance details

K-number
DEN150058
Device name
Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak
Applicant
Bio-Rad Laboratories
Decision
Unknown
Date received
2015-12-16
Decision date
2016-03-28
Days to decision
103 days
Clearance type
Post-NSE
Product code
PMN
Device class
2
Regulation number
866.3920
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
MONOLISA ANTI-HBS EIA (P050048/S010)Bio-Rad Laboratories2025-04-18
BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S009)Bio-Rad Laboratories2013-12-12
BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S008)Bio-Rad Laboratories2012-11-13
BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT (P050048/S007)Bio-Rad Laboratories2012-11-13
BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S004)Bio-Rad Laboratories2011-04-25
MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT (P050048/S005)Bio-Rad Laboratories2010-11-23
BIO-RAD MONOLISA ANTI -HBS EIA (P050048/S006)Bio-Rad Laboratories2010-09-27
BIO-RAD MONOLISA ANTI-HBS EIA (P050048/S002)Bio-Rad Laboratories2010-03-12