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510(k) K924493

DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD by Casco Standards — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1993
Date Received
August 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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