FDA 510(k)

TRIGLYCERIDE REAGENT (COLOR)

K-Number: K801012 · 1980-05-14

Decision Date1980-05-14

Product CodeJGY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDE REAGENT (COLOR) is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Diagnostics. It received FDA 510(k) clearance on 1980-05-14 under 510(k) number K801012. The device is classified under product code JGY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIGLYCERIDE REAGENT (COLOR)?

TRIGLYCERIDE REAGENT (COLOR) is a medical device that received FDA 510(k) clearance on 1980-05-14. The listed applicant is Gilford Diagnostics. The 510(k) number is K801012.

When did TRIGLYCERIDE REAGENT (COLOR) receive FDA 510(k) clearance?

TRIGLYCERIDE REAGENT (COLOR) received FDA 510(k) clearance on 1980-05-14, under 510(k) number K801012.

Who is the listed applicant for TRIGLYCERIDE REAGENT (COLOR)?

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

What is the FDA product code for TRIGLYCERIDE REAGENT (COLOR)?

The FDA product code for TRIGLYCERIDE REAGENT (COLOR) is JGY.

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Other records listing Gilford Diagnostics as applicant

K832094BILIRUBIN CALIBRATORS & CONTROL K831844DIRECT BILIRUBIN REAGENT K831843GILCHEM TOTAL BILIRUBIN REAGENT K823709TRIGLYCERIDE REAGENT (UV)K822739AHBD K822334BILIRUBIN CALIBRATORS

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Related Devices (Code: JGY)

K120664PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEMAbaxis, Inc.K023639PICCOLO TRIGLYCERIDES TEST SYSTEMAbaxis, Inc.K000586BIOSCANNER TRIGLYCERIDES TEST STRIPSPolymer Technology Systems, Inc.K991894BIOSCANNER TRIGLYCERIDES TEST STRIPSPolymer Technology Systems, Inc.K971005TRIGLYCERIDESDerma Media Lab., Inc.K954187TRIGLYCERIDES REAGENTSchiapparelli Biosystems, 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.