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510(k) K792000

LUTEINIZING HORMONE (LH) RIA by Cis Radiopharmaceuticals, Inc. — Product Code CEP

K792000 is an FDA 510(k) premarket notification submitted by Cis Radiopharmaceuticals, Inc. for the device "LUTEINIZING HORMONE (LH) RIA". The FDA issued a decision of Substantially Equivalent on October 30, 1979. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Cis Radiopharmaceuticals, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1979
Date Received
October 5, 1979
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 Cis Radiopharmaceuticals, Inc.

  • K791860 — FERRITIN RIA KIT (December 6, 1979)
  • K792063 — FOLLICLE STIMULATING HORMONE (FSH) KIT (November 20, 1979)
  • K791202 — RIA KIT FOR TRYPSIN (November 5, 1979)
  • K791051 — PROGESTERONE RADIOIMMUNOASSAY KIT (July 24, 1979)
  • K790003 — RIA KIT, PROLACTIN (March 12, 1979)
  • K780982 — KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT (June 22, 1978)
  • K771878 — IRIDIUM 192 WIRES & PINS (October 27, 1977)
  • K760251 — SET, ORAL ADMINISTRATION (September 15, 1976)

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