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510(k) K830749

PLATELET AGGREGOMETER by Chrono-Log Corp. — Product Code JBX

K830749 is an FDA 510(k) premarket notification submitted by Chrono-Log Corp. for the device "PLATELET AGGREGOMETER". The FDA issued a decision of Substantially Equivalent on May 16, 1983. 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
May 16, 1983
Date Received
March 9, 1983
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)
  • 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 JBX

  • K932566 — AGGRO/LINK CONTROL SOFTWARE (November 2, 1993)
  • 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)
  • 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