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FDA 510(k)

TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM

K-Number: K952741 · 1995-08-17

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1995-08-17
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1995-08-17 under 510(k) number K952741. The device is classified under product code CDT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM?

TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-08-17. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K952741.

When did TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM receive FDA 510(k) clearance?

TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM received FDA 510(k) clearance on 1995-08-17, under 510(k) number K952741.

Who is the listed applicant for TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM?

The FDA 510(k) record lists Medical Diagnostic Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM?

The FDA product code for TRIGLYCERIDES (GLYCEROL BLANKING) REAGENT SYSTEM is CDT.

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Other records listing Medical Diagnostic Technologies, Inc. as applicant

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Related Devices (Code: CDT)

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.

K133067ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENTSiemens Healthcare Diagnostics, Inc.K130332VITROS CHEMISTRY PRODUCTS TRIG SLIDESOrtho-Clinical Diagnostics, Inc.K113830VANTERA CLINICAL ANALYZERLiposcienceK102993ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SLSeppim S.A.S.K063804OLYMPUS TRIGLYCERIDE TEST SYSTEMOlympus America, Inc.K043546DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULEDade 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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