Atlas FDA

IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT

FDA 510(k) clearance K981638 · decided 1998-06-12

Clearance details

K-number
K981638
Device name
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
Applicant
Beckman Coulter, Inc.
Decision
Substantially Equivalent
Date received
1998-05-08
Decision date
1998-06-12
Days to decision
35 days
Clearance type
Traditional
Product code
DCK
Device class
2
Regulation number
866.5270
Medical specialty
Immunology
Advisory committee
Immunology
Location
Brea, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
IMMAGE Immunochemistry Systems C-Reactive Protein (CRP) Reagent, Part Number 447280. Inten recall (Z-0921-2010)Beckman Coulter Inc2010-03-02

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