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510(k) K800106

LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS by Radioimmunoassay, Inc. — Product Code CEP

K800106 is an FDA 510(k) premarket notification submitted by Radioimmunoassay, Inc. for the device "LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS". The FDA issued a decision of Substantially Equivalent on February 13, 1980. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Radioimmunoassay, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1980
Date Received
January 16, 1980
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 Radioimmunoassay, Inc.

  • K802135 — TESTOSTERONE RADIOIMMUNOASSY KIT (October 10, 1980)
  • K800107 — FOLLICLE STIMULATING HORMONE (February 13, 1980)
  • K792539 — TRIIODOTHYRONINE RIA SYSTEM (January 16, 1980)
  • K792153 — DIGOXIN RADIOIMMUNOASSAY SYSTEM (November 13, 1979)
  • K792154 — THYROID STIMULATING HORMONE (November 13, 1979)
  • K792036 — CORTISOL RADIOIMMUNOASSAY SYSTEM (October 30, 1979)
  • K780671 — 125 I-T3 UPTAKE REAGENT (June 6, 1978)
  • K780672 — 125 I-T4 RIA REAGENT (June 6, 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