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FDA 510(k)

IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5

K-Number: K991797 · 1999-06-09

ApplicantDiagnostic Products Corp.
Decision Date1999-06-09
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 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 1999-06-09 under 510(k) number K991797. 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 TURBO CK-MB, MODELS LSKCP1, LSKCP5?

IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 is a medical device that received FDA 510(k) clearance on 1999-06-09. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K991797.

When did IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 receive FDA 510(k) clearance?

IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 received FDA 510(k) clearance on 1999-06-09, under 510(k) number K991797.

Who is the listed applicant for IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5?

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 TURBO CK-MB, MODELS LSKCP1, LSKCP5?

The FDA product code for IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 is JHX.

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Other records listing Diagnostic Products Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

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Related Devices (Code: JHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K234005Access CK-MBBeckman Coulter, Inc.K212648VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical DiagnosticsK163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical ApsK120326AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGERadiometer Medical ApsK081360PATHFAST CK-MB-II, PATHFAST MYO-IIMitsubishi Kagaku IatronK051650STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK.Dade Behring, Inc.

Official Source

View on FDA Database →

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

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