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510(k) K903937

TARGET(TM) HOG ONE STEP by V-Tech, Inc. — Product Code JHI

K903937 is an FDA 510(k) premarket notification submitted by V-Tech, Inc. for the device "TARGET(TM) HOG ONE STEP". The FDA issued a decision of Substantially Equivalent on October 22, 1990. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. V-Tech, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1990
Date Received
August 27, 1990
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 V-Tech, Inc.

  • K914303 — TARGET(TM)-HOG (October 11, 1991)
  • K910892 — TARGET(TM) CANNABINOIDS-V TEST (April 3, 1991)
  • K910893 — TARGET(TM) CANNABINOIDS-R TEST (April 3, 1991)
  • K910739 — TARGET AMPHETAMINE/METHAMPHETAMINE-R (READER METH) (March 21, 1991)
  • K910738 — TARGET AMPHETAMINE/METHAMPHETAMINE-V (VISUAL METH) (March 19, 1991)
  • K910122 — TARGET COCAINE METABOLITE-R (March 19, 1991)
  • K910123 — TARGET COCAINE METABOLITE-V (March 19, 1991)
  • K890978 — TARGET OPIATES-R (November 17, 1989)
  • K890979 — TARGET OPIATES-V (October 4, 1989)
  • K890295 — TARGET(TM) CK-MB (August 15, 1989)

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