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510(k) K830664

HUMAN INTRACT PARATHYROID HORMONE BY by Immuno Nuclear Corp. — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1983
Date Received
March 3, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Parathyroid Hormone
Device Class
Class II
Regulation Number
862.1545
Review Panel
CH
Submission Type

Other clearances by Immuno Nuclear Corp.

  • K863743 — BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT (December 15, 1986)
  • 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)
  • 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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