Atlas FDA

AXSYM SALICYLATE

FDA 510(k) clearance K951290 · decided 1995-08-08

Clearance details

K-number
K951290
Device name
AXSYM SALICYLATE
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1995-03-21
Decision date
1995-08-08
Days to decision
140 days
Clearance type
Traditional
Product code
DKJ
Device class
2
Regulation number
862.3830
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
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
ADVIA CHEMISTRY SALICYLATE REAGENT (K093939)Siemens Healthcare Diagnostics2010-05-19
SALICYLATE-SL ASSAY (K042329)Diagnostic Chemicals , Ltd.2004-12-27
SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K020794)Bayer Diagnostics Corp.2002-07-11
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR (K014173)Beckman Coulter, Inc.2002-02-15
EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL (K011878)Syva Co.2001-08-13
SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 (K981872)Diagnostic Chemicals , Ltd.1998-06-29
SALICYLATE ASSAY (ACE), CATALOGUE NUMBER 501-71 (K980032)Diagnostic Chemicals , Ltd.1998-03-02
PARAMAX SALICYLATE REAGENT (K964715)Dade Intl., Inc.1997-04-25
SALICYLATE ASSAY (K961131)Diagnostic Reagents, Inc.1996-04-29
ABUSCREEN ONLINE(R) CALIBRATORS (K946000)Roche Diagnostic Systems, Inc.1995-01-25
DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD (K904301)E.I. Dupont DE Nemours & Co., Inc.1990-11-09
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI) (K902356)Eastman Kodak Company1990-07-16

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