Home / 510(k) Clearances / K954993

510(k) K954993

QUIX RAPID PREGNANCY STRIP TEST by Guardian Scientific, Corp. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 1995
Date Received
October 31, 1995
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 Guardian Scientific, Corp.

  • K972156 — QUIX RAPID E. COLI O157 STRIP TEST (October 16, 1997)
  • K954994 — TRUST (October 18, 1996)
  • K954995 — QUIX RAPID CHOLERA STRIP TEST (August 15, 1996)

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)