FDA 510(k) Application Details - K770126

Device Classification Name Calibrator, Secondary

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510(K) Number K770126
Device Name Calibrator, Secondary
Applicant UNION CARBIDE CORP.

, US
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Regulation Number 862.1150

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Classification Product Code JIT
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Date Received 01/21/1977
Decision Date 01/31/1977
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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