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510(k) K834038

RIANEN FOLLICLE STIMULATING HORMONE by New England Nuclear — Product Code CGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1984
Date Received
November 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Follicle-Stimulating Hormone
Device Class
Class I
Regulation Number
862.1300
Review Panel
CH
Submission Type

Other clearances by New England Nuclear

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  • K833376 — RIANEN LUTEINIZING HORMONE RIA KIT (December 20, 1983)
  • K831345 — RIANEN PROLACTIN 125I KIT (June 8, 1983)
  • K801245 — ATOMLIGHT (LIQUID SCINTILLATION SOLUTION (June 20, 1980)
  • K792175 — RIANEN, VITAMIN B12 ASSAY SYSTEM (November 13, 1979)
  • K790817 — RIA KIT, QUANTITATION OF PROSTATIC ACID (May 7, 1979)
  • K782110 — RIA KIT, RIANEN CORTISOL (January 26, 1979)
  • K781888 — ASSAY SYSTEM, FERRITIN I KIT (January 10, 1979)
  • K781495 — RIANEN ASSAY SYSTEM, 125I KIT (September 14, 1978)

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  • K002450 — GENUA MENOPAUSE MONITOR TEST KIT (January 12, 2001)
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  • K964693 — ELECSYS FSH ASSAY (December 16, 1996)