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510(k) K921778

DIRECTDRAW SUPERSERUM by International Technidyne Corp. — Product Code GIM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1992
Date Received
April 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vacuum Sample, With Anticoagulant
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

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  • K990449 — HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE (April 13, 1999)
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