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FDA 510(k)

COBAS READY TRIGLYCERIDE REAGENT

K-Number: K896231 · 1990-02-16

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1990-02-16
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS READY TRIGLYCERIDE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1990-02-16 under 510(k) number K896231. 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 COBAS READY TRIGLYCERIDE REAGENT?

COBAS READY TRIGLYCERIDE REAGENT is a medical device that received FDA 510(k) clearance on 1990-02-16. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K896231.

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

COBAS READY TRIGLYCERIDE REAGENT received FDA 510(k) clearance on 1990-02-16, under 510(k) number K896231.

Who is the listed applicant for COBAS READY TRIGLYCERIDE REAGENT?

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

What is the FDA product code for COBAS READY TRIGLYCERIDE REAGENT?

The FDA product code for COBAS READY TRIGLYCERIDE REAGENT is CDT.

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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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