Home / 510(k) Clearances / K781310

510(k) K781310

HUMAN CHORIONIC GONADO.-BETA RIA KIT by Diagnostics Biochem Canada, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1978
Date Received
July 31, 1978
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 Diagnostics Biochem Canada, Inc.

  • K030730 — FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT (August 18, 2003)
  • K014120 — TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA) (February 8, 2002)
  • K864966 — ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE (January 9, 1987)
  • K832297 — HYDROXYPROGESTERONE-17 (September 1, 1983)
  • K801729 — ANDROSTENEDIONE RADIOIMMUNOASSAY KIT (October 31, 1980)

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)