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510(k) K934521

SPQ MALB CONTROL LEVEL II by Incstar Corp. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1993
Date Received
September 17, 1993
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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