Atlas FDA

TIBC

FDA 510(k) clearance K981654 · decided 1998-07-22

Clearance details

K-number
K981654
Device name
TIBC
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1998-05-11
Decision date
1998-07-22
Days to decision
72 days
Clearance type
Traditional
Product code
JMO
Device class
1
Regulation number
862.1415
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Irving, TX, 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
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT (K113438)Alfa Wassermann Diagnostic Technologies, Inc.2012-06-01
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 (K061464)Ortho-Clinical Diagnostics, Inc.2006-06-15
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT (K052867)Ortho-Clinical Diagnostics, Inc.2005-12-23
OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 (K041793)Olympus America, Inc.2004-07-16
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 (K013102)Wiener Laboratories Saic2001-11-13
BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC) (K012340)Bayer Corp.2001-10-01
DIRECT TIBC KIT (K000781)Reference Diagnostics, Inc.2000-05-02
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE (K994115)Dade Behring, Inc.2000-01-28
TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02 (K991666)A.P. Total Care, Inc.1999-06-30
TOTAL IRON, MODELS FE 109-01, FE 109-02 (K991244)A.P. Total Care, Inc.1999-05-25
MAGNETIC TIBC KIT (K990216)Reference Diagnostics, Inc.1999-02-16
UIBC (K982041)Abbott Laboratories1998-07-30

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