Atlas FDA

AXSYM FREE THYROXINE ( FREE T4 )

FDA 510(k) clearance K934544 · decided 1994-06-21

Clearance details

K-number
K934544
Device name
AXSYM FREE THYROXINE ( FREE T4 )
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1993-09-22
Decision date
1994-06-21
Days to decision
272 days
Clearance type
Traditional
Product code
CEC
Device class
2
Regulation number
862.1695
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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VIDAS FT4 (K132058)Biomerieux S.A.2015-06-08
DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT (K140859)Siemens Healthcare Diagnostics, Inc.2014-11-26
DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART (K140842)Siemens Healthcare Diagnostics, Inc.2014-11-26
ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET (K131244)Roche Diagnostics2014-01-27
ADVIA CENTAUR FT4, ADVIA CENTAUR T4 (K132249)Siemens Healthcare Diagnostics, Inc.2013-09-13
LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3 (K121951)DiaSorin, Inc.2013-04-04

Recalls involving this device

RecordFirmDate
Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M recall (Z-1130-03)Abbott Laboratories HPD/ADD2003-08-13

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