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FDA 510(k)

COBAS INTEGRA ACETAMINOPHEN

K-Number: K991598 · 1999-07-22

ApplicantRoche Diagnostics Corp.
Decision Date1999-07-22
Product CodeLDP
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COBAS INTEGRA ACETAMINOPHEN is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 1999-07-22 under 510(k) number K991598. The device is classified under product code LDP. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS INTEGRA ACETAMINOPHEN?

COBAS INTEGRA ACETAMINOPHEN is a medical device that received FDA 510(k) clearance on 1999-07-22. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K991598.

When did COBAS INTEGRA ACETAMINOPHEN receive FDA 510(k) clearance?

COBAS INTEGRA ACETAMINOPHEN received FDA 510(k) clearance on 1999-07-22, under 510(k) number K991598.

Who is the listed applicant for COBAS INTEGRA ACETAMINOPHEN?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBAS INTEGRA ACETAMINOPHEN?

The FDA product code for COBAS INTEGRA ACETAMINOPHEN is LDP.

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Other records listing Roche Diagnostics Corp. as applicant

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Related Devices (Code: LDP)

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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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