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510(k) K041502

THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY by Haemoscope Corp. — Product Code JOZ

K041502 is an FDA 510(k) premarket notification submitted by Haemoscope Corp. for the device "THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY". The FDA issued a decision of Substantially Equivalent on September 1, 2004. The device falls under product code JOZ (System, Automated Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Haemoscope Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2004
Date Received
June 7, 2004
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 Haemoscope Corp.

  • K062604 — RAPIDTEG TEG-ACT TEST (January 31, 2007)
  • K002177 — THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES (September 14, 2000)
  • K993678 — THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES (May 5, 2000)
  • K954437 — THROMBELASTOGRAPH COAGULATION ANALYZER 3000S (January 30, 1996)
  • K904204 — THROMBELASTOGRAPH (November 1, 1990)
  • K895844 — THROMBELASTOGRAPH(R) (October 24, 1989)

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