FDA 510(k)

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

K-Number: K004002 · 2001-02-14

Decision Date2001-02-14

Product CodeJHX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 2001-02-14 under 510(k) number K004002. The device is classified under product code JHX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) is a medical device that received FDA 510(k) clearance on 2001-02-14. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K004002.

When did IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) receive FDA 510(k) clearance?

IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) received FDA 510(k) clearance on 2001-02-14, under 510(k) number K004002.

Who is the listed applicant for IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)?

The FDA 510(k) record lists Diagnostic Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600)?

The FDA product code for IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS); IMMULITE 2000 CK-MB, MODEL L2KMB2 (200 TESTS), L2KMB6 (600) is JHX.

Related Clinical Trials

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Other records listing Diagnostic Products Corp. as applicant

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCIN K034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I K033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER K032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE K023152IMMULITE 2000 ALLERGEN-SPECIFIC IGE K023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

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Related Devices (Code: JHX)

K234005Access CK-MBBeckman Coulter, Inc.K212648VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical Diagnostics K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps K120326AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGERadiometer Medical Aps K081360PATHFAST CK-MB-II, PATHFAST MYO-IIMitsubishi Kagaku Iatron K051650STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.Dade Behring, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.