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SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR

FDA 510(k) clearance K013076 · decided 2001-12-12

Clearance details

K-number
K013076
Device name
SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR
Applicant
Beckman Coulter, Inc.
Decision
Substantially Equivalent
Date received
2001-09-14
Decision date
2001-12-12
Days to decision
89 days
Clearance type
Traditional
Product code
LEH
Device class
2
Regulation number
862.3950
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Brea, CA, US
Third-party review
No
Expedited review
No

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IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (K063045)Diagnostic Products Corp.2006-12-05
ENZYME IMMUNOASSAY, VANCOMYCIN (K060586)Roche Diagnostics Corp.2006-05-11
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VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III (K043386)Ortho-Clinical Diagnostics, Inc.2005-02-07
CEDIA VANCOMYCIN ASSAY (K032811)Microgenics Corp.2003-11-24
EMIT 2000 VANCOMYCIN ASSAY (K020692)Dade Behring, Inc.2002-05-10
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Recalls involving this device

RecordFirmDate
SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824. recall (Z-0886-06)Beckman Coulter Inc2006-05-18

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