Atlas FDA

Access CK-MB

FDA 510(k) clearance K234005 · decided 2024-02-16

Clearance details

K-number
K234005
Device name
Access CK-MB
Applicant
Beckman Coulter, Inc.
Decision
Substantially Equivalent
Date received
2023-12-19
Decision date
2024-02-16
Days to decision
59 days
Clearance type
Traditional
Product code
JHX
Device class
2
Regulation number
862.1215
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Chaska, MN, 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
VITROS Immunodiagnostic Products CK-MB Reagent Pack (K212648)Ortho Clinical Diagnostics2022-01-28
AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (K163462)Radiometer Medical Aps2017-09-21
AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE (K120326)Radiometer Medical Aps2012-11-21
PATHFAST CK-MB-II, PATHFAST MYO-II (K081360)Mitsubishi Kagaku Iatron2009-08-17
STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. (K051650)Dade Behring, Inc.2005-09-08
ARCHITECT STAT CK-MB IMMUNOASSAY (K041596)Fisher Diagnostics2004-07-21
RAMP CK-MB ASSAY (K033747)Response Biomedical Corp.2004-05-17
IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (K034055)Diagnostic Products Corp.2004-01-21
CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 (K030012)Beckman Coulter, Inc.2003-01-17
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (K022118)Diagnostic Products Corp.2002-07-22
MODIFICATION TO ALPHA DX SYSTEM (K013118)First Medical, Inc.2001-10-15
IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) (K004002)Diagnostic Products Corp.2001-02-14

Recalls involving this device

No recalls on record reference this clearance.

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