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510(k) K851148

TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE by Euro-Diagnostics BV — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1985
Date Received
March 21, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class
Class II
Regulation Number
862.1690
Review Panel
CH
Submission Type

Other clearances by Euro-Diagnostics BV

  • K851332 — BLHI LUTEINIZING HORMONE (July 9, 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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