Atlas FDA

ACCESS TOTAL T4 ASSAY

FDA 510(k) clearance K023369 · decided 2002-12-09

Clearance details

K-number
K023369
Device name
ACCESS TOTAL T4 ASSAY
Applicant
Beckman Coulter, Inc.
Decision
Substantially Equivalent
Date received
2002-10-08
Decision date
2002-12-09
Days to decision
62 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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VITROS® Automation Solutions (K160495)Ortho-Clinical Diagnostics, Inc.2016-10-18
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ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 (K030860)Monobind2003-08-22
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
ACCUWELL T4-EIA (K972974)Neometrics, Inc.1997-10-06

Recalls involving this device

RecordFirmDate
Access Total T4 Calibrator, Catalog No. 33805 recall (Z-1922-2026)Beckman Coulter, Inc.2026-04-22
Access Total T4, REF 33800, IVD, thyroxine reagent assay. recall (Z-1303-2024)Beckman Coulter, Inc.2024-03-15
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 C recall (Z-0613-2013)Beckman Coulter Inc.2012-12-22
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805, Subsequent Product Co recall (Z-3027-2011)Beckman Coulter Inc.2011-08-16
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
Access AFP (on DxI 9000 Analyzer) (P980041/S051)Beckman Coulter, Inc.2025-11-03
Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015)Beckman Coulter, Inc.2025-10-17
Access Hybritech p2PSA (P090026/S032)Beckman Coulter, Inc.2025-06-16
Access Hybritech free PSA (P970038/S046)Beckman Coulter, Inc.2025-05-15
Access Hybritech PSA (P850048/S060)Beckman Coulter, Inc.2024-09-04
Access Hybritech PSA reagent pack (P850048/S059)Beckman Coulter, Inc.2023-05-25
Access AFP Reagents on the Access Immunoassay Systems (P980041/S050)Beckman Coulter, Inc.2022-12-16
Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057)Beckman Coulter, Inc.2022-12-16