Home / 510(k) Clearances / K061257

510(k) K061257

DBEST HCG PANEL TEST KIT by Ameritek USA, Inc. — Product Code JHI

K061257 is an FDA 510(k) premarket notification submitted by Ameritek USA, Inc. for the device "DBEST HCG PANEL TEST KIT". The FDA issued a decision of Substantially Equivalent on May 4, 2007. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Ameritek USA, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2007
Date Received
May 4, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Ameritek USA, Inc.

  • K071242 — DBEST ONE STEP OCCULT BLOOD TEST KITS (March 6, 2008)

Other clearances for product code JHI

  • K241919 — Innovita HCG Pregnancy Rapid Combo Test (August 2, 2024)
  • K203272 — Alltest Pregnancy Rapid Combo Test Cassette (January 31, 2022)
  • K172322 — Atellica IM Total hCG (ThCG) (March 29, 2018)
  • K172257 — TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Resu (December 22, 2017)
  • K152768 — Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregn (February 24, 2016)
  • K130456 — WUNDER PREGNANCY TEST (April 8, 2014)
  • K132834 — FASTEP S10 HCG SERUM/URINE COMBO TEST (January 9, 2014)
  • K131166 — SOFIA(R) HCG FIA (August 2, 2013)
  • K123844 — CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND H (May 30, 2013)
  • K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS (July 17, 2012)

FDA data resources