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FDA 510(k)

TRIGLYCERIDES REAGENT (INT, COLORIMETRIC)

K-Number: K860731 · 1986-04-07

ApplicantTrace Scientific , Ltd.
Decision Date1986-04-07
Product CodeJGY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDES REAGENT (INT, COLORIMETRIC) 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 1986-04-07 under 510(k) number K860731. 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 TRIGLYCERIDES REAGENT (INT, COLORIMETRIC)?

TRIGLYCERIDES REAGENT (INT, COLORIMETRIC) is a medical device that received FDA 510(k) clearance on 1986-04-07. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K860731.

When did TRIGLYCERIDES REAGENT (INT, COLORIMETRIC) receive FDA 510(k) clearance?

TRIGLYCERIDES REAGENT (INT, COLORIMETRIC) received FDA 510(k) clearance on 1986-04-07, under 510(k) number K860731.

Who is the listed applicant for TRIGLYCERIDES REAGENT (INT, COLORIMETRIC)?

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 TRIGLYCERIDES REAGENT (INT, COLORIMETRIC)?

The FDA product code for TRIGLYCERIDES REAGENT (INT, COLORIMETRIC) is JGY.

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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: JGY)

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.

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.

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