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510(k) K964609

ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE by Array Medical, Inc. — Product Code JBP

K964609 is an FDA 510(k) premarket notification submitted by Array Medical, Inc. for the device "ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE". The FDA issued a decision of Substantially Equivalent on March 6, 1997. The device falls under product code JBP (Activated Whole Blood Clotting Time), a Class II device regulated under 21 CFR 864.7140. Array Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1997
Date Received
November 18, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Whole Blood Clotting Time
Device Class
Class II
Regulation Number
864.7140
Review Panel
HE
Submission Type

Other clearances by Array Medical, Inc.

  • K990398 — PLATELETWORKS (December 1, 1999)
  • K983649 — MAX-ACT (December 11, 1998)

Other clearances for product code JBP

  • K223635 — Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (January 4, 2023)
  • K062604 — RAPIDTEG TEG-ACT TEST (January 31, 2007)
  • K032952 — AIACT KIT (December 12, 2003)
  • K023582 — I-STAT KAOLIN ACT TEST (September 8, 2003)
  • K020914 — ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 (May 23, 2002)
  • K013078 — ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 (January 10, 2002)
  • K002528 — SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER O (August 31, 2000)
  • K994194 — (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT (March 28, 2000)
  • K992571 — I-STAT SYSTEM (February 10, 2000)
  • K992851 — ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYST (January 14, 2000)

FDA data resources