Atlas FDA

ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY

FDA 510(k) clearance K940549 · decided 1994-04-06

Clearance details

K-number
K940549
Device name
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
Applicant
Bio-Rad Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1994-02-07
Decision date
1994-04-06
Days to decision
58 days
Clearance type
Traditional
Product code
CEP
Device class
1
Regulation number
862.1485
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Chaska, MN, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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Recalls involving this device

RecordFirmDate
The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quan recall (Z-0572-2013)Beckman Coulter Inc.2012-12-20

PMA approvals by this applicant

RecordFirmDate
MONOLISA ANTI-HBC IGM EIA (P060034/S008)Bio-Rad Laboratories, Inc.2014-03-19
BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S007)Bio-Rad Laboratories, Inc.2013-12-12
BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S007)Bio-Rad Laboratories, Inc.2013-12-12
BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S006)Bio-Rad Laboratories, Inc.2012-11-13
BIO-RAD MONOLISA ANTI-HBC IGM EIA (P060034/S006)Bio-Rad Laboratories, Inc.2012-11-13
BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S005)Bio-Rad Laboratories, Inc.2011-04-28
BIO-RAD MONOLISA ANTI-HBC EIA (P060031/S003)Bio-Rad Laboratories, Inc.2010-12-30
MONOLISA ANTI-HBC IGM EIA (P060034/S005)Bio-Rad Laboratories, Inc.2010-11-23