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INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC — Roche Diagnostics Corp. (510(k) K990992)

INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC — Roche Diagnostics Corp. (510(k) K990992) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC; Applicant: Roche Diagnostics Corp.; Clearance track: 510(k).

Device nameINTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
ApplicantRoche Diagnostics Corp.
Clearance track510(k)
Submission numberK990992
DecisionSubstantially Equivalent
Decision date1999-09-30
Date received1999-03-24
Product codeLCP
Device class2
Medical specialtyHematology
Applicant locationIN, US
SourceopenFDA device

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