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510(k) K161329

Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel by Chrono-Log Corp. — Product Code JOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2016
Date Received
May 12, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Automated Platelet Aggregation
Device Class
Class II
Regulation Number
864.5700
Review Panel
HE
Submission Type

Other clearances by Chrono-Log Corp.

  • K050265 — CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 (October 14, 2005)
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  • K962426 — CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592 (October 22, 1996)
  • K945414 — RISTOCETIN COFACTOR ASSAY KIT (January 11, 1995)
  • K940792 — AGGRO/LINK VW COFACTOR SOFTWARE (October 13, 1994)
  • K932566 — AGGRO/LINK CONTROL SOFTWARE (November 2, 1993)
  • K922800 — PLATELET AGGREGATION REAGENTS (August 26, 1992)
  • K851025 — AGGRO/LINK COMPUTER INTERFACE (June 12, 1985)
  • K850592 — PLATELET AGGREGATION REAGENT (May 13, 1985)
  • K830749 — PLATELET AGGREGOMETER (May 16, 1983)

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