Home / 510(k) Clearances / K884863

510(k) K884863

ELECTRA 900C AUTOMATIC COAGULATION TIMER by Medical Laboratory Automation Systems, Inc. — Product Code GKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1989
Date Received
November 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Coagulation, Automated
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)
  • K903405 — CHLAMYDIA ACCU-CULSHURE TM (October 16, 1990)
  • K903406 — VIRAL ACCU-CULSHURE TM (October 16, 1990)
  • K901645 — ANAEROBIC ACCU-CULSHURE(TM) (July 16, 1990)
  • K894052 — ELECTRA 1000C AUTOMATIC COAGULATION TIMER (July 27, 1989)
  • K871687 — TYTEM(R) REAGENT DISPENSER (May 20, 1987)

Other clearances for product code GKP

  • K242127 — ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP (August 16, 2024)
  • K231031 — ACL TOP Family 70 Series (June 21, 2023)
  • K160276 — ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP (March 3, 2016)
  • K150877 — ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP (December 13, 2015)
  • K091980 — ACL TOP 700 LAS (September 22, 2009)
  • K073377 — ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) (May 4, 2008)
  • K063679 — ACL TOP (January 12, 2007)
  • K033414 — ACL TOP MODEL, TOP (January 12, 2004)
  • K031377 — SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -5 (September 8, 2003)
  • K023362 — FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLU (December 9, 2002)