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510(k) K851332

BLHI LUTEINIZING HORMONE by Euro-Diagnostics BV — Product Code CEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1985
Date Received
April 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Luteinizing Hormone
Device Class
Class I
Regulation Number
862.1485
Review Panel
CH
Submission Type

Other clearances by Euro-Diagnostics BV

  • K851148 — TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE (April 29, 1985)
  • K850053 — BACI 6 -ADRENOCORTICOTROOP HORMONE (April 8, 1985)
  • K843930 — IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I (October 30, 1984)
  • K842478 — PROLACTIN IRMA (September 14, 1984)

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