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FDA 510(k)

COBAS REAGENT FOR TRIGLYCERIDES & COBAS

K-Number: K801298 · 1980-07-08

ApplicantRoche Analytical Instruments, Inc.
Decision Date1980-07-08
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS REAGENT FOR TRIGLYCERIDES & COBAS is the device name listed in this FDA 510(k) record. The listed applicant is Roche Analytical Instruments, Inc.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801298. 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 REAGENT FOR TRIGLYCERIDES & COBAS?

COBAS REAGENT FOR TRIGLYCERIDES & COBAS is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Roche Analytical Instruments, Inc.. The 510(k) number is K801298.

When did COBAS REAGENT FOR TRIGLYCERIDES & COBAS receive FDA 510(k) clearance?

COBAS REAGENT FOR TRIGLYCERIDES & COBAS received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801298.

Who is the listed applicant for COBAS REAGENT FOR TRIGLYCERIDES & COBAS?

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

What is the FDA product code for COBAS REAGENT FOR TRIGLYCERIDES & COBAS?

The FDA product code for COBAS REAGENT FOR TRIGLYCERIDES & COBAS is CDT.

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Other records listing Roche Analytical Instruments, 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.

K801299COBAS CK-NAC REAGENTK801295COBAS REAGENT FOR A-AMYLASEK801296COBAS REAGENT FOR CHOLESTEROLK801297COBAS REAGENT FOR GLUCOSE RAPIDK801243COBAS REAGENTS FOR URIC ACIDK801242COBAS REAGENT FOR ALKALINE PHOSPHATASE

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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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