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FDA 510(k)

COBAS CORE FSH EIA

K-Number: K930304 · 1993-09-21

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1993-09-21
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS CORE FSH EIA 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 1993-09-21 under 510(k) number K930304. The device is classified under product code CGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS CORE FSH EIA?

COBAS CORE FSH EIA is a medical device that received FDA 510(k) clearance on 1993-09-21. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K930304.

When did COBAS CORE FSH EIA receive FDA 510(k) clearance?

COBAS CORE FSH EIA received FDA 510(k) clearance on 1993-09-21, under 510(k) number K930304.

Who is the listed applicant for COBAS CORE FSH EIA?

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 CORE FSH EIA?

The FDA product code for COBAS CORE FSH EIA is CGJ.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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Related Devices (Code: CGJ)

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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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