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FDA 510(k)

INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT

K-Number: K870827 · 1987-03-13

ApplicantIntersect Systems, Inc.
Decision Date1987-03-13
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Intersect Systems, Inc.. It received FDA 510(k) clearance on 1987-03-13 under 510(k) number K870827. 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 INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT?

INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT is a medical device that received FDA 510(k) clearance on 1987-03-13. The listed applicant is Intersect Systems, Inc.. The 510(k) number is K870827.

When did INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT receive FDA 510(k) clearance?

INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT received FDA 510(k) clearance on 1987-03-13, under 510(k) number K870827.

Who is the listed applicant for INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT?

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

What is the FDA product code for INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT?

The FDA product code for INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT is CDT.

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Other records listing Intersect Systems, Inc. as applicant

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K021636ALBUMIN REAGENTK011972DIRECT BILIRUBIN REAGENTK011692HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENTK003892TOTAL BILIRUBIN REAGENTK983937DUAL VIAL CREATININE REAGENTK974833CK-NAC REAGENT

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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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