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510(k) K944999

SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 by More Diagnostics — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1995
Date Received
October 13, 1994
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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  • K941876 — WHOLE BLOOD VOLATILES CONTROL, LEVELS 1 AND 2 (July 28, 1994)

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