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510(k) K883430

PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST by Disease Detection International, Inc. — Product Code LCX

K883430 is an FDA 510(k) premarket notification submitted by Disease Detection International, Inc. for the device "PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST". The FDA issued a decision of Substantially Equivalent on January 30, 1989. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), 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
January 30, 1989
Date Received
August 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Test, Pregnancy, Hcg, Over The Counter
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)
  • K911826 — IMMUNOCARD HCG ONE STEP (I-S) TEST KIT (July 19, 1991)
  • 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)
  • 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 LCX

  • K251040 — MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital P (September 9, 2025)
  • K251053 — Shinetell PlusTM Digital Early Pregnancy Test (July 15, 2025)
  • K250117 — FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette (February 13, 2025)
  • K242135 — Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synth (January 31, 2025)
  • K243573 — FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Casse (January 15, 2025)
  • K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (December 20, 2024)
  • K240242 — HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test (October 11, 2024)
  • K241978 — Shinetell Digital Pregnancy Test (August 13, 2024)
  • K240643 — MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnanc (June 21, 2024)
  • K232715 — Distinct® Digital Pregnancy Test (May 31, 2024)

FDA data resources