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FDA 510(k)

HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT

K-Number: K933722 · 1996-06-13

ApplicantHorizon Diagnostics, Inc.
Decision Date1996-06-13
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Horizon Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-06-13 under 510(k) number K933722. 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 HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT?

HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT is a medical device that received FDA 510(k) clearance on 1996-06-13. The listed applicant is Horizon Diagnostics, Inc.. The 510(k) number is K933722.

When did HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT receive FDA 510(k) clearance?

HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT received FDA 510(k) clearance on 1996-06-13, under 510(k) number K933722.

Who is the listed applicant for HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT?

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

What is the FDA product code for HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT?

The FDA product code for HORIZON DIAGNOSTICS TRIGLYCERIDES-GPO REAGENT is CDT.

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Other records listing Horizon Diagnostics, Inc. 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.

K971566CREATINE KINASE-MB REAGENT SETK935712IRON/TIBC REAGENTK930678AMYLASEK934533BUN-300/BUN-500 UREA NITROGEN REAGENTK930679DIRECT BILIRUBINK930074IN-VITRO DIAGNOSTIC REAGENT SET

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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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