Home / 510(k) Clearances / K863743

510(k) K863743

BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT by Immuno Nuclear Corp. — Product Code DHB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1986
Date Received
September 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Radioallergosorbent (Rast) Immunological
Device Class
Class II
Regulation Number
866.5750
Review Panel
IM
Submission Type

Other clearances by Immuno Nuclear Corp.

  • K863973 — ELM ALLERGEN DISC (December 1, 1986)
  • 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)
  • K862938 — JUNE GRASS ALLERGEN DISC (August 15, 1986)
  • K862176 — RUSSIAN THISTLE ALLERGEN DISC (August 15, 1986)
  • K862939 — ORCHARD GRASS ALLERGEN DISC (August 15, 1986)
  • K862265 — COTTONWOOD ALLERGEN DISC (August 15, 1986)
  • K862174 — TIMOTHY ALLERGEN DISC (August 6, 1986)

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