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510(k) K811994

RADIOIMMUNOASSAY LUTEINIZING HORMONE by Endocrine-Metabolic Center — Product Code CEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1981
Date Received
July 14, 1981
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 Endocrine-Metabolic Center

  • K821131 — RADIOIMMUNOASSAY PARATHYROID HORMONE MID (June 2, 1982)
  • K811993 — RADIOIMMUNOASSAY, FOLLICLE STIMULATING (August 3, 1981)
  • K810948 — RADIOIMMUNOASSAY THYROID STIM. HORM. KIT (April 17, 1981)
  • K810351 — RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE (February 23, 1981)
  • K800188 — EMC-M-180, T3 UPTAKE - 100 TUBES (February 13, 1980)
  • K800187 — EMC-M-175, THYROXINE - 100 TUBES (February 13, 1980)
  • K790602 — RIA, DIGNXIN-125-I (July 30, 1979)
  • K790630 — RIA, INSULIN, DOUBLE ANTIBODY (July 24, 1979)

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