Atlas FDA

ACCESS(R) THYROXINE ASSAY

FDA 510(k) clearance K926475 · decided 1993-06-15

Clearance details

K-number
K926475
Device name
ACCESS(R) THYROXINE ASSAY
Applicant
Bio-Rad Laboratories, Inc.
Decision
Substantially Equivalent
Date received
1992-12-29
Decision date
1993-06-15
Days to decision
168 days
Clearance type
Traditional
Product code
KLI
Device class
2
Regulation number
862.1700
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
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
VITROS® Automation Solutions (K160495)Ortho-Clinical Diagnostics, Inc.2016-10-18
ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT (K131515)Alfa Wassermann2013-08-14
GSP NEONATAL THYROXINE (T4) (K103484)Wallac Oy, A Subsidiary of Perkinelmer, Inc.2011-04-22
ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL (K082638)Siemens Healthcare Diagnostics, Inc.2009-02-26
ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 (K030860)Monobind2003-08-22
ACCESS TOTAL T4 ASSAY (K023369)Beckman Coulter, Inc.2002-12-09
REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105) (K001603)Repromedix Corp.2000-10-05
SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORS (K000600)Syva Co., Dade Behring, Inc.2000-03-27
BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007 (K991432)Biocheck, Inc.1999-06-02
OPTICOAT T4 EIA KIT (K982298)Biotecx Laboratories, Inc.1999-02-03
ABBOTT ARCHITECT TOTAL T4 (K983440)Abbott Laboratories1998-11-25
ACE T4 REAGENT T4 CALIBRATORS (K981377)Schiapparelli Biosystems, Inc.1998-06-10

Recalls involving this device

RecordFirmDate
Access Total T4 Reagent Kit, Part Number: 33800, Lot Numbers (s): All reagent pack lots Th recall (Z-1949-2011)Beckman Coulter Inc.2011-04-12

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