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510(k) K962664

ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER by Medical Laboratory Automation Systems, Inc. — Product Code GKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1996
Date Received
July 9, 1996
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.

  • 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)
  • K871687 — TYTEM(R) REAGENT DISPENSER (May 20, 1987)

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