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FDA 510(k)

COBAS ALPHA

K-Number: K910222 · 1991-02-27

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1991-02-27
Product CodeJJG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS ALPHA 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 1991-02-27 under 510(k) number K910222. 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 ALPHA?

COBAS ALPHA is a medical device that received FDA 510(k) clearance on 1991-02-27. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K910222.

When did COBAS ALPHA receive FDA 510(k) clearance?

COBAS ALPHA received FDA 510(k) clearance on 1991-02-27, under 510(k) number K910222.

Who is the listed applicant for COBAS ALPHA?

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 ALPHA?

The FDA product code for COBAS ALPHA is JJG.

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Other records listing Roche Diagnostic Systems, 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.K903626BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISABeckman Instruments, Inc.K893854COBAS FARA II CENTRIFUGAL ANALYZERRoche Diagnostic Systems, 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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