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510(k) K903531

ANTICARDIOLIPIN ANTIBODY TEST SYSTEM by Medical Innovations Corp. — Product Code GFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1991
Date Received
August 6, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Partial Thromboplastin
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
Submission Type

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  • K943685 — MIC DISPOSABLE SNARE (November 1, 1994)
  • K926581 — MIC TRANSGASTRIC JEJUNAL TUBE (September 28, 1994)
  • K921652 — MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT (May 2, 1994)
  • K921370 — MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION (May 2, 1994)
  • K924065 — MIC PEG TUBE (February 17, 1994)
  • K922667 — MIC LOW PROFILE GASTROSTOMY TUBE (December 1, 1993)
  • K913320 — MIL CM-II COAGULATION MACHINE (June 16, 1992)
  • K900464 — MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE (December 5, 1990)

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  • K992712 — SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 (December 6, 1999)