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510(k) K820357

LUTEINIZING HORMONE KIT by Pcl-Ria, Inc. — Product Code CEP

K820357 is an FDA 510(k) premarket notification submitted by Pcl-Ria, Inc. for the device "LUTEINIZING HORMONE KIT". The FDA issued a decision of Substantially Equivalent on March 25, 1982. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Pcl-Ria, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1982
Date Received
February 9, 1982
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 Pcl-Ria, Inc.

  • K830526 — B-GCG SYSTEM BY RIA (April 5, 1983)
  • K823014 — DIGOXIN KIT (November 1, 1982)
  • K822935 — THYROID STIMULATING HORMONE (November 1, 1982)
  • K822612 — T3 UPTAKE KITS (September 30, 1982)
  • K820886 — THYROXINE T4 KIT (April 16, 1982)
  • K820358 — FOLLICLE STIMULATING HORMONE KIT (March 26, 1982)
  • K812666 — THYROXINE (T4) 125I (October 2, 1981)
  • K810867 — FOLLICLE STIMULATING HORMONE (FSH) (April 14, 1981)
  • K810852 — FOLLICLE STIMULATING HORMONE ANTISERUM (April 8, 1981)
  • K810741 — LUTEINIZING HORMONE (March 31, 1981)

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