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510(k) K841478

RIANEN CYCLIC-AMP RADIOIMMUNOASSAY by New England Nuclear — Product Code CHO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1984
Date Received
April 9, 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

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  • K781888 — ASSAY SYSTEM, FERRITIN I KIT (January 10, 1979)
  • K781495 — RIANEN ASSAY SYSTEM, 125I KIT (September 14, 1978)

Other clearances for product code CHO

  • K860253 — AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT) (March 14, 1986)
  • K844135 — PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU (March 5, 1985)
  • 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)