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510(k) K833376

RIANEN LUTEINIZING HORMONE RIA KIT by New England Nuclear — Product Code CEP

K833376 is an FDA 510(k) premarket notification submitted by New England Nuclear for the device "RIANEN LUTEINIZING HORMONE RIA KIT". The FDA issued a decision of Substantially Equivalent on December 20, 1983. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. New England Nuclear has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1983
Date Received
September 28, 1983
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 New England Nuclear

  • K841478 — RIANEN CYCLIC-AMP RADIOIMMUNOASSAY (June 14, 1984)
  • K840301 — RIANEN ESTRIOL RADIOIMMUNOASSAY KIT (March 30, 1984)
  • K834038 — RIANEN FOLLICLE STIMULATING HORMONE (January 30, 1984)
  • 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)

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)
  • K991386 — EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATI (May 25, 1999)
  • K991466 — EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), O (May 25, 1999)

FDA data resources