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FDA 510(k)

COBAS-BIO CENTRIFUGAL ANALYZER

K-Number: K792671 · 1980-01-17

ApplicantHoffmann-La Roche, Inc.
Decision Date1980-01-17
Product CodeJJG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS-BIO CENTRIFUGAL ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Hoffmann-La Roche, Inc.. It received FDA 510(k) clearance on 1980-01-17 under 510(k) number K792671. The device is classified under product code JJG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS-BIO CENTRIFUGAL ANALYZER?

COBAS-BIO CENTRIFUGAL ANALYZER is a medical device that received FDA 510(k) clearance on 1980-01-17. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K792671.

When did COBAS-BIO CENTRIFUGAL ANALYZER receive FDA 510(k) clearance?

COBAS-BIO CENTRIFUGAL ANALYZER received FDA 510(k) clearance on 1980-01-17, under 510(k) number K792671.

Who is the listed applicant for COBAS-BIO CENTRIFUGAL ANALYZER?

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

What is the FDA product code for COBAS-BIO CENTRIFUGAL ANALYZER?

The FDA product code for COBAS-BIO CENTRIFUGAL ANALYZER is JJG.

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Other records listing Hoffmann-La Roche, Inc. as applicant

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Related Devices (Code: JJG)

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.

K972409AG CHEMISTRY ANALYZER SYSTEMLandmark Scientific, Inc.K942782PICCOLO(TM)Abaxis, Inc.K934592EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTORAbaxis, Inc.K920942OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZEROlympus Corp.K910222COBAS ALPHARoche Diagnostic Systems, Inc.K903626BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISABeckman Instruments, 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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