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510(k) K923123

HCG PREGNANCY ONE STEP TEST STRIP by Tcpi, Inc. — Product Code JHI

K923123 is an FDA 510(k) premarket notification submitted by Tcpi, Inc. for the device "HCG PREGNANCY ONE STEP TEST STRIP". The FDA issued a decision of Substantially Equivalent on September 9, 1992. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Tcpi, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1992
Date Received
June 26, 1992
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 Tcpi, Inc.

  • K981363 — ONE STEP URINE DRUG OF ABUSE: PHENCYCLIDINE (PCP) TEST (December 22, 1998)
  • K972960 — HEALTH CHECK URI-TEST PROTEIN IN URINE (October 7, 1998)
  • K981197 — ONE STEP URINE DRUG OF ABUSE AMPHETAMINE TEST (June 16, 1998)
  • K980776 — ONE STEP URINE DRUG OF ABUSE: BENZODIAZEPINE TEST (April 29, 1998)
  • K951853 — ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) (August 20, 1996)
  • K954968 — HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST (July 26, 1996)
  • K954685 — URITEST - NITRITE IN URINE TEST (July 22, 1996)
  • K955353 — ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT (March 19, 1996)
  • K952096 — ONE STEP URINE DRUG OF ABUSE OPIATE TEST (OPIUM/HEROIN/MORPHINE) (August 17, 1995)
  • K951892 — ONE STEP URINE DRUG OF ABUSE COCAINE TEST (August 17, 1995)

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