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510(k) K854686

TE-25 COAGURO METER by Future Impex Corp. — Product Code JBP

K854686 is an FDA 510(k) premarket notification submitted by Future Impex Corp. for the device "TE-25 COAGURO METER". The FDA issued a decision of Substantially Equivalent on June 4, 1986. The device falls under product code JBP (Activated Whole Blood Clotting Time), a Class II device regulated under 21 CFR 864.7140. Future Impex Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1986
Date Received
November 20, 1985
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 Future Impex Corp.

  • K861487 — ST-90 SPIRO ANALIZER (June 23, 1986)
  • K854687 — ERMA HB-METER MODEL 303N (June 4, 1986)
  • K854685 — DIGITAL-9 KEY LEUCOCYTE COUNTER (April 4, 1986)
  • K854677 — ERMA PC-604 BLOOD CELL COUNTER (February 24, 1986)
  • K854678 — ERMA PC-602 PC-603 BLOOD CELL COUNTER (February 24, 1986)
  • K854679 — PHOTIC-100 SPECTROPHOTOMETER (February 20, 1986)
  • K843934 — MODEL {M-102 I-CHANNEL ELECTRO CARDIOGRAPH UNIT (November 20, 1984)
  • K843700 — ST-200A W/MAXIMAL VOLUNTARY VENTILLAT- (October 24, 1984)
  • K843984 — PM-80 PULMOTESTER (October 24, 1984)
  • K832431 — FUKUNDA SANGYA UNITS PULMOTESTER PM60 (September 29, 1983)

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