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510(k) K983649

MAX-ACT by Array Medical, Inc. — Product Code JBP

K983649 is an FDA 510(k) premarket notification submitted by Array Medical, Inc. for the device "MAX-ACT". The FDA issued a decision of Substantially Equivalent on December 11, 1998. 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
December 11, 1998
Date Received
October 16, 1998
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)
  • K964609 — ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC (March 6, 1997)

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