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510(k) K851332

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

K851332 is an FDA 510(k) premarket notification submitted by Euro-Diagnostics BV for the device "BLHI LUTEINIZING HORMONE". The FDA issued a decision of Substantially Equivalent on July 9, 1985. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Euro-Diagnostics BV has at least 4 other 510(k) clearances on record.

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)

Other clearances for product code CEP

  • K013582 — MAYBE?MOM MINI OVULATION MICROSCOPE (January 16, 2003)
  • K022829 — INSTANT-VIEW LH OVULATION PREDICTING TEST (November 5, 2002)
  • K021409 — AT HOME OVULATION TEST, MODEL 9032 (May 24, 2002)
  • K013874 — CLEARPLANE EASY OVULATION TEST (February 19, 2002)
  • K013323 — TCI-31 LIFELONG OVULATION TESTER (December 5, 2001)
  • K012252 — QUIK-CHECK OVULATION PREDICTOR (August 24, 2001)
  • K010244 — SURE CHECK OVULATION PREDICTOR (May 2, 2001)
  • K002867 — INVERNESS MEDICAL OVULATION PREDICTOR TEST (October 12, 2000)
  • K991466 — EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), O (May 25, 1999)
  • K991386 — EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATI (May 25, 1999)

FDA data resources