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510(k) K844135

PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU by Immuno Nuclear Corp. — Product Code CHO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1985
Date Received
October 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Cyclic Amp
Device Class
Class II
Regulation Number
862.1230
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)
  • K862176 — RUSSIAN THISTLE ALLERGEN DISC (August 15, 1986)
  • K862938 — JUNE GRASS ALLERGEN DISC (August 15, 1986)
  • K862265 — COTTONWOOD ALLERGEN DISC (August 15, 1986)
  • K862939 — ORCHARD GRASS ALLERGEN DISC (August 15, 1986)

Other clearances for product code CHO

  • K860253 — AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT) (March 14, 1986)
  • K841478 — RIANEN CYCLIC-AMP RADIOIMMUNOASSAY (June 14, 1984)
  • K823504 — CYCLIC ADENOSINE MONOPHOSHATE BY RADIO (January 28, 1983)
  • K811746 — KING DIAGNOSTICS CHOLESTEROL-FE TEST (July 10, 1981)
  • K811273 — CYCLIC AMP RADIOIMMUNOASSAY KIT [125I] (May 27, 1981)