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510(k) K983460

STAR AUTOMATED MULTI-PARAMETRIC ANALYZER by American Bioproducts Co. — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1998
Date Received
September 30, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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  • K955040 — AT-III CONTROL PLASMA KIT (January 31, 1996)
  • K954017 — ASSERACHROM FREE PROTEIN S KIT (November 13, 1995)

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