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510(k) K974508

DBEST ONE-STEP OVULATION TEST by Ameritek, Inc. — Product Code CEP

K974508 is an FDA 510(k) premarket notification submitted by Ameritek, Inc. for the device "DBEST ONE-STEP OVULATION TEST". The FDA issued a decision of Substantially Equivalent on February 2, 1998. The device falls under product code CEP (Radioimmunoassay, Luteinizing Hormone), a Class I device regulated under 21 CFR 862.1485. Ameritek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1998
Date Received
December 1, 1997
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 Ameritek, Inc.

  • K001215 — DBEST HCG 2 IU/ML TEST KIT (June 22, 2000)
  • K990873 — DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE (September 1, 1999)
  • K990681 — DBSET MULTIDRUG SCREEN TEST KIT (July 15, 1999)
  • K984269 — DBEST OCCULT BLOOD TEST KIT (May 11, 1999)
  • K983190 — DBEST OPIATES TEST KIT (November 18, 1998)
  • K983188 — DBEST TETRAHYDROCANNABINOL TEST KIT (November 18, 1998)
  • K983189 — DBEST METHAMPHETAMINES TEST KIT (November 18, 1998)
  • K983191 — DBEST COCAINE TEST KIT (November 18, 1998)
  • K981504 — DBEST AMPHETAMINES TEST KIT (August 6, 1998)
  • K973957 — DBEST ONE-STEP HCG SERUM/URINE TEST (December 17, 1997)

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

FDA data resources