Atlas FDA

ACCESS DIGOXIN ASSAY

FDA 510(k) clearance K925802 · decided 1993-01-13

Clearance details

K-number
K925802
Device name
ACCESS DIGOXIN ASSAY
Applicant
Bio-Rad Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1992-11-16
Decision date
1993-01-13
Days to decision
58 days
Clearance type
Traditional
Product code
KXT
Device class
2
Regulation number
862.3320
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Chaska, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
ADVIA Centaur® Digoxin assay (K193397)Siemens Healthcare Diagnostics, Inc.2021-07-16
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II (K153301)Roche Diagnostics2016-04-08
RANDOX DIGOXIN ASSAY (K102346)Randox Laboratories, Ltd.2011-10-14
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 (K093441)Siemens Healthcare Diagnostics2010-04-07
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 (K082953)Biokit, S.A.2008-12-22
AXSYM DIGOXIN III (K061249)Abbott Laboratories2006-06-02
BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM (K033007)Bayer Diagnostics Corp.2003-11-14
QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM (K023058)Seradyn2002-10-24
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) (K012301)Diagnostic Products Corp.2001-09-19
RANDOX DIGOXIN (K011302)Randox Laboratories, Ltd.2001-07-02
EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 (K011920)Syva Co., Dade Behring, Inc.2001-07-02
DIGOXIN IMMUNOASSAY (K983323)Diagnostic Reagents, Inc.1998-11-12

Recalls involving this device

RecordFirmDate
Access Immunoasay Systems Digoxin Reagent recall (Z-0576-05)Beckman Coulter Inc2005-03-08

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