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510(k) K932566

AGGRO/LINK CONTROL SOFTWARE by Chrono-Log Corp. — Product Code JBX

K932566 is an FDA 510(k) premarket notification submitted by Chrono-Log Corp. for the device "AGGRO/LINK CONTROL SOFTWARE". The FDA issued a decision of Substantially Equivalent on November 2, 1993. The device falls under product code JBX (Aggregrometer, Platelet), a Class II device regulated under 21 CFR 864.6675. Chrono-Log Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1993
Date Received
May 27, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aggregrometer, Platelet
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)
  • 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)

Other clearances for product code JBX

  • K912774 — ARACHIDONIC ACID (August 22, 1991)
  • K881829 — PAT PLATELET AGGREGATION TEST (July 1, 1988)
  • K862775 — ASSERACHROM B-TG KIT (October 22, 1986)
  • K851025 — AGGRO/LINK COMPUTER INTERFACE (June 12, 1985)
  • K850592 — PLATELET AGGREGATION REAGENT (May 13, 1985)
  • K832929 — RISTOCETIN PLATELET AGGREGA-REAGENT TEST (September 29, 1983)
  • K830749 — PLATELET AGGREGOMETER (May 16, 1983)
  • K821005 — PLATELET AGGREGATION PROFILER #PAP-4 (June 1, 1982)
  • K811290 — ARACHIDONIC ACID (July 27, 1981)
  • K781710 — BUFFER, COLLAGEN REAGENT AND DILUENT (October 24, 1978)

FDA data resources