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510(k) K851169

ELECTRA 800 AUTOMATIC COAGULATION TIMER by Medical Laboratory Automation Systems, Inc. — Product Code KQG

K851169 is an FDA 510(k) premarket notification submitted by Medical Laboratory Automation Systems, Inc. for the device "ELECTRA 800 AUTOMATIC COAGULATION TIMER". The FDA issued a decision of Substantially Equivalent on June 24, 1985. The device falls under product code KQG (Instrument, Coagulation), a Class II device regulated under 21 CFR 864.5400. Medical Laboratory Automation Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1985
Date Received
March 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Coagulation
Device Class
Class II
Regulation Number
864.5400
Review Panel
HE
Submission Type

Other clearances by Medical Laboratory Automation Systems, Inc.

  • K962664 — ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER (September 10, 1996)
  • K944227 — ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER (February 3, 1995)
  • K931206 — ELECTRA 1600C AUTOMATIC COAGULATION TIMER (August 23, 1993)
  • K923220 — THROMBIN CLOT TIME TEST PROCEDURE (September 29, 1992)
  • K903638 — GASTRO-INTESTINAL ACCU-CULSHURE TM (January 18, 1991)
  • K903406 — VIRAL ACCU-CULSHURE TM (October 16, 1990)
  • K903405 — CHLAMYDIA ACCU-CULSHURE TM (October 16, 1990)
  • K901645 — ANAEROBIC ACCU-CULSHURE(TM) (July 16, 1990)
  • K894052 — ELECTRA 1000C AUTOMATIC COAGULATION TIMER (July 27, 1989)
  • K884863 — ELECTRA 900C AUTOMATIC COAGULATION TIMER (February 3, 1989)

Other clearances for product code KQG

  • K050821 — COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM (August 16, 2005)
  • K021976 — FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON (October 25, 2002)
  • K992130 — PACIFIC HEMOSTASIS THROMBOSCREEN 400C (September 3, 1999)
  • K991321 — PACIFIC HEMOSTASIS THROMBOSCREEN 200 (June 21, 1999)
  • K983475 — HEMOCHRON RESPONSE (May 3, 1999)
  • K902614 — ELVI 828 DIGICLOT MULTISCAN (November 8, 1990)
  • K900685 — CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER (April 16, 1990)
  • K862047 — COAGULATOR (8 CHANNEL) (September 29, 1986)
  • K852492 — COAGULATOR (August 13, 1985)
  • K823131 — KOAGULAB 40-A AUTOMATED COAGULATION SYS (December 9, 1982)

FDA data resources