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FDA 510(k)

TRIGLYCERIDES (GPO-TRINDER)

K-Number: K880628 · 1988-03-15

ApplicantTech-Co, Inc.
Decision Date1988-03-15
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDES (GPO-TRINDER) is the device name listed in this FDA 510(k) record. The listed applicant is Tech-Co, Inc.. It received FDA 510(k) clearance on 1988-03-15 under 510(k) number K880628. 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 TRIGLYCERIDES (GPO-TRINDER)?

TRIGLYCERIDES (GPO-TRINDER) is a medical device that received FDA 510(k) clearance on 1988-03-15. The listed applicant is Tech-Co, Inc.. The 510(k) number is K880628.

When did TRIGLYCERIDES (GPO-TRINDER) receive FDA 510(k) clearance?

TRIGLYCERIDES (GPO-TRINDER) received FDA 510(k) clearance on 1988-03-15, under 510(k) number K880628.

Who is the listed applicant for TRIGLYCERIDES (GPO-TRINDER)?

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

What is the FDA product code for TRIGLYCERIDES (GPO-TRINDER)?

The FDA product code for TRIGLYCERIDES (GPO-TRINDER) is CDT.

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Other records listing Tech-Co, 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.

K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTK923376VISUAL HCG PREGNANCY TESTK920766T4 EIA BEAD ASSAYK920716DIRECT PREGNANCY TESTK902574POTASSIUM REAGENT SETK901561IRON/TOTAL IRON BINDING CAPACITY

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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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