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510(k) K850892

SOMATOMEDIN C BY RADIOIMMUNOASSAY by Immuno Nuclear Corp. — Product Code CFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1985
Date Received
March 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Human Growth Hormone
Device Class
Class I
Regulation Number
862.1370
Review Panel
CH
Submission Type

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  • K863844 — IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC (October 29, 1986)
  • K863123 — IMMUNO BIOTECH MUGWART ALLERGEN DISC (October 1, 1986)
  • K863098 — MEADOW FESCUE ALLERGEN DISC (September 15, 1986)
  • K862266 — MAPLE ALLERGEN DISC (August 19, 1986)
  • K862939 — ORCHARD GRASS ALLERGEN DISC (August 15, 1986)
  • K862265 — COTTONWOOD ALLERGEN DISC (August 15, 1986)
  • K862938 — JUNE GRASS ALLERGEN DISC (August 15, 1986)
  • K862176 — RUSSIAN THISTLE ALLERGEN DISC (August 15, 1986)

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