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510(k) K032951

CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A by Chrono-Log Corp. — Product Code JOZ

K032951 is an FDA 510(k) premarket notification submitted by Chrono-Log Corp. for the device "CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A". The FDA issued a decision of Substantially Equivalent on April 2, 2004. The device falls under product code JOZ (System, Automated Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Chrono-Log Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2004
Date Received
September 22, 2003
Clearance Type
Traditional
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.

  • 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)
  • 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)

Other clearances for product code JOZ

  • K191364 — T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS (February 14, 2020)
  • K181777 — AggreGuide A-100 ADP (March 29, 2019)
  • K163274 — AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument (April 5, 2017)
  • K161329 — Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 (December 2, 2016)
  • K141427 — ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST (July 24, 2015)
  • K140893 — CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY (January 3, 2015)
  • K122162 — AGGREGUIDE (December 20, 2013)
  • K103555 — MULTIPLATE 5.0 AGGREGOMETER (July 27, 2012)
  • K060489 — DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS (July 21, 2006)
  • K050265 — CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 (October 14, 2005)

FDA data resources