Atlas FDA

SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR

FDA 510(k) clearance K014173 · decided 2002-02-15

Clearance details

K-number
K014173
Device name
SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR
Applicant
Beckman Coulter, Inc.
Decision
Substantially Equivalent
Date received
2001-12-20
Decision date
2002-02-15
Days to decision
57 days
Clearance type
Traditional
Product code
DKJ
Device class
2
Regulation number
862.3830
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Brea, CA, 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
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
AXSYM SALICYLATE (K951290)Abbott Laboratories1995-08-08
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

RecordFirmDate
SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when used i recall (Z-2238-2009)Beckman Coulter Inc2009-09-30

PMA approvals by this applicant

RecordFirmDate
Access AFP (on DxI 9000 Analyzer) (P980041/S051)Beckman Coulter, Inc.2025-11-03
Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015)Beckman Coulter, Inc.2025-10-17
Access Hybritech p2PSA (P090026/S032)Beckman Coulter, Inc.2025-06-16
Access Hybritech free PSA (P970038/S046)Beckman Coulter, Inc.2025-05-15
Access Hybritech PSA (P850048/S060)Beckman Coulter, Inc.2024-09-04
Access Hybritech PSA reagent pack (P850048/S059)Beckman Coulter, Inc.2023-05-25
Access AFP Reagents on the Access Immunoassay Systems (P980041/S050)Beckman Coulter, Inc.2022-12-16
Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057)Beckman Coulter, Inc.2022-12-16