Atlas FDA

AXSYM CA 15-3

FDA 510(k) clearance K963926 · decided 1997-09-15

Clearance details

K-number
K963926
Device name
AXSYM CA 15-3
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1996-09-30
Decision date
1997-09-15
Days to decision
350 days
Clearance type
Traditional
Product code
MOI
Device class
2
Regulation number
866.6010
Medical specialty
Immunology
Advisory committee
Immunology
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Abbott Laboratories

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Access BR Monitor (K240403)Beckman Coulter, Inc.2024-05-09
IMMULITE® 2000 BR-MA (K233946)Siemens Healthcare Diagnostics Products, Ltd.2024-03-13
Lumipulse G CA15-3 (K192524)Fujirebio Diagnostics,Inc.2020-09-04
ADVIA Centaur BR (K193489)Siemens Healthcare Diagnostics, Inc.2020-02-13
ADVIA Centaur CA 15-3 assay (K192777)Siemens Healthcare Diagnostics, Inc.2019-11-22
Elecsys CA 15-3 II (K181492)Roche Diagnostics2018-06-22
Elecsys CA 15-3 II (K171605)Roche Diagnostics2018-02-20
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 (K100344)Siemens Healthcare Diagnostics2011-04-18
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 (K072612)Beckman Coulter, Inc.2007-10-26
ARCHITECT CA 15-3 ASSAY (K042732)Fujirebio Diagnostics,Inc.2004-12-22
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 (K033036)Beckman Coulter, Inc.2004-02-03
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022178)Bayer Diagnostics Corp.2002-11-12

Recalls involving this device

RecordFirmDate
AxSYM CA 15-3 Reagent Pack; list 03B42; 100 test pack; an in vitro diagnostic; Abbott Labo recall (Z-1027-2007)Abbott Laboratories2007-07-11
CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15 recall (Z-1244-06)Abbott Laboratories MPG2006-07-18
Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bott recall (Z-0679-03)Abbott Laboratories HPD/ADD2003-03-26
CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactiv recall (Z-0680-03)Abbott Laboratories HPD/ADD2003-03-26

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