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FDA 510(k)

RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)

K-Number: K871509 · 1987-05-08

ApplicantTrace Scientific , Ltd.
Decision Date1987-05-08
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL) is the device name listed in this FDA 510(k) record. The listed applicant is Trace Scientific , Ltd.. It received FDA 510(k) clearance on 1987-05-08 under 510(k) number K871509. 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 RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)?

RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL) is a medical device that received FDA 510(k) clearance on 1987-05-08. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K871509.

When did RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL) receive FDA 510(k) clearance?

RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL) received FDA 510(k) clearance on 1987-05-08, under 510(k) number K871509.

Who is the listed applicant for RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)?

The FDA 510(k) record lists Trace Scientific , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)?

The FDA product code for RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL) is CDT.

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Other records listing Trace Scientific , Ltd. 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.

K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTK981123UREAK962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)K961114AST INCORPORATING DSTK961123ALT INCORPORATING DSTK952488TRACE COBAS MIRA RANGE

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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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