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FDA 510(k)

INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC

K-Number: K990992 · 1999-09-30

ApplicantRoche Diagnostics Corp.
Decision Date1999-09-30
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC 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 1999-09-30 under 510(k) number K990992. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC?

INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC is a medical device that received FDA 510(k) clearance on 1999-09-30. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K990992.

When did INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC receive FDA 510(k) clearance?

INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC received FDA 510(k) clearance on 1999-09-30, under 510(k) number K990992.

Who is the listed applicant for INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC?

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 INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC?

The FDA product code for INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC is LCP.

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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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