Atlas FDA

ABBOTT ARCHITECT TOTAL T4

FDA 510(k) clearance K983440 · decided 1998-11-25

Clearance details

K-number
K983440
Device name
ABBOTT ARCHITECT TOTAL T4
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1998-09-29
Decision date
1998-11-25
Days to decision
57 days
Clearance type
Traditional
Product code
KLI
Device class
2
Regulation number
862.1700
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Abbott Park, IL, 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
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

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30