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510(k) K962399

HEPATITIS NEGATIVE CONTROL by Pyramid Biological Corp. — Product Code MJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1996
Date Received
June 21, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Serological, Negative Control
Device Class
Class I
Regulation Number
862.1660
Review Panel
MI
Submission Type

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  • K944515 — SERUM PROTEIN CONTROLS (November 17, 1994)
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