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510(k) K903405

CHLAMYDIA ACCU-CULSHURE TM by Medical Laboratory Automation Systems, Inc. — Product Code LIO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1990
Date Received
July 31, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Specimen Collection
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
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)
  • 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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