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FDA 510(k)

COBAS EIA(TM) PHOTOMETER

K-Number: K881877 · 1988-06-10

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1988-06-10
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS EIA(TM) PHOTOMETER 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 1988-06-10 under 510(k) number K881877. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS EIA(TM) PHOTOMETER?

COBAS EIA(TM) PHOTOMETER is a medical device that received FDA 510(k) clearance on 1988-06-10. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K881877.

When did COBAS EIA(TM) PHOTOMETER receive FDA 510(k) clearance?

COBAS EIA(TM) PHOTOMETER received FDA 510(k) clearance on 1988-06-10, under 510(k) number K881877.

Who is the listed applicant for COBAS EIA(TM) PHOTOMETER?

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 EIA(TM) PHOTOMETER?

The FDA product code for COBAS EIA(TM) PHOTOMETER is JJQ.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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Related Devices (Code: JJQ)

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.

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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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