Atlas FDA

ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209

FDA 510(k) clearance K981985 · decided 1998-09-24

Clearance details

K-number
K981985
Device name
ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209
Applicant
Beckman Coulter, Inc.
Decision
Substantially Equivalent
Date received
1998-06-05
Decision date
1998-09-24
Days to decision
111 days
Clearance type
Traditional
Product code
DHX
Device class
2
Regulation number
866.6010
Medical specialty
Immunology
Advisory committee
Immunology
Location
Chaska, MN, US
Third-party review
No
Expedited review
No

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VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS (K041322)Ortho-Clinical Diagnostics, Inc.2004-06-17
ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS (K031270)Beckman Coulter, Inc.2003-05-06
ST AIA-PACK CEA ENZYME IMMUNOASSAY (K023893)Tosoh Medics, Inc.2002-12-18
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K013568)Bayer Corp.2001-12-21
MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206 (K991707)Beckman1999-06-01
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK (K990943)Ortho-Clinical Diagnostics, Inc.1999-06-01

Recalls involving this device

RecordFirmDate
Access Immunoassay system CEA, in vitro diagnostic, Part No. 33200 recall (Z-1313-06)Beckman Coulter Inc2006-08-01

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