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510(k) K946193

FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 by More Diagnostics — Product Code GIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 1995
Date Received
December 20, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Fibrinogen Control
Device Class
Class II
Regulation Number
864.7340
Review Panel
HE
Submission Type

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Other clearances for product code GIL

  • K962407 — N/T PROTEIN CONTROL PY (July 29, 1996)
  • K946265 — FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 (August 24, 1995)
  • K935598 — PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 (May 2, 1995)
  • K951012 — N/T PROTEIN CONTROL PY (April 17, 1995)
  • K934741 — LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2 (September 8, 1994)
  • K915462 — FIBRINOGEN CONTROL (March 4, 1992)
  • K833352 — GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL (November 3, 1983)