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510(k) K920504

MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT by Medix Biotech, Inc. — Product Code CEP

K920504 is an FDA 510(k) premarket notification submitted by Medix Biotech, Inc. for the device "MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT". The FDA issued a decision of Substantially Equivalent on March 2, 1992. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Medix Biotech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 1992
Date Received
February 5, 1992
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 Medix Biotech, Inc.

  • K952873 — MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) (September 8, 1995)
  • K952319 — CONTRAST & RAPID HCG URINE/SERUM TST (June 20, 1995)
  • K932482 — MEDIX BIOTECH BESTEST STREP A CAT. NO. BSF1010 (July 18, 1994)
  • K932758 — MEDIX BIOTECH BESTEST HCG-URINE TEST KIT (September 28, 1993)
  • K925436 — MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT (December 28, 1992)
  • K924259 — MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100 (November 25, 1992)
  • K922047 — IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064 (August 5, 1992)
  • K921700 — TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093 (June 29, 1992)
  • K920712 — MEDIX BIOTECH THROXINE ENZYME IMMUNOASSAY TEST KIT (March 27, 1992)
  • K920345 — PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED) (March 18, 1992)

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