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510(k) K771198

LUMI-AGGREGOMETER by Chrono-Log Corp. — Product Code JBY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1977
Date Received
July 1, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aggregometer, Platelet, Photo-Optical Scanning
Device Class
Class II
Regulation Number
864.6675
Review Panel
HE
Submission Type

Other clearances by Chrono-Log Corp.

  • K161329 — Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 (December 2, 2016)
  • K050265 — CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 (October 14, 2005)
  • K032951 — CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A (April 2, 2004)
  • 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)

Other clearances for product code JBY

  • K912201 — PACKS-4 (TM) ANALYZER (August 16, 1991)