IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)

FDA 510(k) clearance K004002 · decided 2001-02-14

Clearance details

K-number: K004002
Device name: IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)
Applicant: Diagnostic Products Corp.
Decision: Substantially Equivalent
Date received: 2000-12-26
Decision date: 2001-02-14
Days to decision: 50 days
Clearance type: Traditional
Product code: JHX
Device class: 2
Regulation number: 862.1215
Medical specialty: Clinical Chemistry
Advisory committee: Clinical Chemistry
Location: Los Angeles, CA, US
Third-party review: No
Expedited review: No

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Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
Access CK-MB (K234005)	Beckman Coulter, Inc.	2024-02-16
VITROS Immunodiagnostic Products CK-MB Reagent Pack (K212648)	Ortho Clinical Diagnostics	2022-01-28
AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX (K163462)	Radiometer Medical Aps	2017-09-21
AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE (K120326)	Radiometer Medical Aps	2012-11-21
PATHFAST CK-MB-II, PATHFAST MYO-II (K081360)	Mitsubishi Kagaku Iatron	2009-08-17
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 Diagnostics	2004-07-21
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

Record	Firm	Date
IMMULITE/IMMULITE 1000 CK-MB LKMB --- Catalog number: LKMB1 (100 tests), LKMB5 (500 tests) recall (Z-1271-2012)	Siemens Healthcare Diagnostics	2012-03-21
IMMULITE 2000/IMMULITE 2000 XPi CK-MB L2KMB --- Catalog number: L2KMB2 (200 tests), L2KMB6 recall (Z-1273-2012)	Siemens Healthcare Diagnostics	2012-03-21