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510(k) K911826

IMMUNOCARD HCG ONE STEP (I-S) TEST KIT by Disease Detection International, Inc. — Product Code JHI

K911826 is an FDA 510(k) premarket notification submitted by Disease Detection International, Inc. for the device "IMMUNOCARD HCG ONE STEP (I-S) TEST KIT". The FDA issued a decision of Substantially Equivalent on July 19, 1991. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Disease Detection International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1991
Date Received
April 24, 1991
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 Disease Detection International, Inc.

  • K943252 — PRO-STEP LH OVULATION PREDICTION TEST (October 25, 1994)
  • K925303 — PRO-STEP PT HCG (June 15, 1993)
  • K925125 — PRO-STEP HCG (January 13, 1993)
  • K902571 — MODIFICATION OF SEROCARD RUBELLA IGG TEST (September 5, 1990)
  • K903070 — SEROCARD HSV IGG ANTIBODY TEST KIT (August 9, 1990)
  • K895912 — IMMUNOCARD HCG II-S TEST KIT (December 1, 1989)
  • K896109 — IMMUNOCARD STREP A TEST (November 29, 1989)
  • K884247 — MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT (April 10, 1989)
  • K884246 — MODIFIED DDI SEROCARD HERPES IGG TEST KIT (April 10, 1989)
  • K884249 — MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT (April 10, 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