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FDA 510(k)

COBAS(R) CORE IGE TOTAL EIA

K-Number: K930890 · 1993-08-05

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1993-08-05
Product CodeDGC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

COBAS(R) CORE IGE TOTAL 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 1993-08-05 under 510(k) number K930890. The device is classified under product code DGC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS(R) CORE IGE TOTAL EIA?

COBAS(R) CORE IGE TOTAL EIA is a medical device that received FDA 510(k) clearance on 1993-08-05. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K930890.

When did COBAS(R) CORE IGE TOTAL EIA receive FDA 510(k) clearance?

COBAS(R) CORE IGE TOTAL EIA received FDA 510(k) clearance on 1993-08-05, under 510(k) number K930890.

Who is the listed applicant for COBAS(R) CORE IGE TOTAL 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(R) CORE IGE TOTAL EIA?

The FDA product code for COBAS(R) CORE IGE TOTAL EIA is DGC.

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Related Devices (Code: DGC)

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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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