Home / 510(k) Clearances / K922290

510(k) K922290

SINGLE-STEP PREGNANCY, HCG TEST by American Medical Products, Inc. — Product Code JHI

K922290 is an FDA 510(k) premarket notification submitted by American Medical Products, Inc. for the device "SINGLE-STEP PREGNANCY, HCG TEST". The FDA issued a decision of Substantially Equivalent on July 9, 1992. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. American Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1992
Date Received
May 15, 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 American Medical Products, Inc.

  • K862221 — E-Z CLEAN (September 12, 1986)
  • K861251 — AMP CLOSED URINARY DRAINAGE BAG, 1011 & 1011N (April 17, 1986)
  • K830881 — AMPERCIDE DISINFECTANT ACCESSORY TO - (June 2, 1983)
  • K823827 — AMP 80/2 OUTFLOW MONITOR MODIFICATION (March 17, 1983)
  • K822549 — CCPD CYCLER SET W/5 PRONGED SAFE LOCK (October 13, 1982)
  • K822543 — CAPD SAFE LOCK TRANSFER SET (October 13, 1982)
  • K822548 — SAFE LOCK CATHETER S-3 (October 13, 1982)
  • K822545 — CCPD CYCLER SET W/5 PRONGED CONNECTOR (October 13, 1982)
  • K822546 — SAFE LOCK SEALING CAPS (October 13, 1982)
  • K822550 — SAFE LOCK TITANIUM ADAPTER SET (October 13, 1982)

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