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FDA 510(k)

TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL

K-Number: K905226 · 1990-12-11

ApplicantEnzyme Technology, Inc.
Decision Date1990-12-11
Product CodeJGY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL is the device name listed in this FDA 510(k) record. The listed applicant is Enzyme Technology, Inc.. It received FDA 510(k) clearance on 1990-12-11 under 510(k) number K905226. 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 (GPO) REAGENT, UNIVERSAL?

TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL is a medical device that received FDA 510(k) clearance on 1990-12-11. The listed applicant is Enzyme Technology, Inc.. The 510(k) number is K905226.

When did TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL receive FDA 510(k) clearance?

TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL received FDA 510(k) clearance on 1990-12-11, under 510(k) number K905226.

Who is the listed applicant for TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL?

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

What is the FDA product code for TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL?

The FDA product code for TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL is JGY.

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Other records listing Enzyme Technology, 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.

K912027CALCIUM (ARSENAZO III) REAGENT, UNIVERSALK912028URIC ACID (URICASE) REAGENT, UNIVERSALK905227GLUCOSE (HK) REAGENT, UNIVERSALK896073CHOLESTEROL, UNIVERSAL ET

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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