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FDA 510(k)

TRIGLYCERIDE REAGENT SET

K-Number: K812838 · 1981-12-03

ApplicantAnco Medical Reagents & Assoc.
Decision Date1981-12-03
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Anco Medical Reagents & Assoc.. It received FDA 510(k) clearance on 1981-12-03 under 510(k) number K812838. 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 TRIGLYCERIDE REAGENT SET?

TRIGLYCERIDE REAGENT SET is a medical device that received FDA 510(k) clearance on 1981-12-03. The listed applicant is Anco Medical Reagents & Assoc.. The 510(k) number is K812838.

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

TRIGLYCERIDE REAGENT SET received FDA 510(k) clearance on 1981-12-03, under 510(k) number K812838.

Who is the listed applicant for TRIGLYCERIDE REAGENT SET?

The FDA 510(k) record lists Anco Medical Reagents & Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIGLYCERIDE REAGENT SET?

The FDA product code for TRIGLYCERIDE REAGENT SET is CDT.

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Other records listing Anco Medical Reagents & Assoc. 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.

K842440SICKLE CELL STAT A/S HETEROZYGOUS-ERYTHK831871SICKLE-HEME A/S CONTROLS & A/A CONTROLK821658HEMOGLOBIN REAGENTK821526ACID PHOSPHATASE REAGENT SETK821102MEGNESIUM REAGENT KITK820951ENZYMATIC CHOLESTEROL KIT

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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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