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510(k) K991515

INSURE PREGNANCY TEST by Inbios Intl., Inc. — Product Code DHA

K991515 is an FDA 510(k) premarket notification submitted by Inbios Intl., Inc. for the device "INSURE PREGNANCY TEST". The FDA issued a decision of Substantially Equivalent on May 28, 1999. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Inbios Intl., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1999
Date Received
April 30, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Inbios Intl., Inc.

  • DEN100020 — DENV DETECT IGM CAPTURE ELISA (April 8, 2011)
  • K041817 — WEST NILE DETECT IGM ELISA (November 19, 2004)
  • K023483 — KALAZAR DETECT (May 6, 2003)
  • K001092 — GENERIC BLOOD GLUCOSE TEST STRIP (July 26, 2000)
  • K992695 — INSURE PRO TEST (October 18, 1999)

Other clearances for product code DHA

  • K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (May 8, 2024)
  • K223690 — iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) (December 11, 2023)
  • K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track (June 5, 2023)
  • K230790 — Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT (May 19, 2023)
  • K221990 — Access Total ßhCG (5th IS) (December 27, 2022)
  • K212221 — Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemilu (December 13, 2021)
  • K203227 — Elecsys HCG STAT (August 18, 2021)
  • K200210 — ADVIA Centaur® Total hCG assay (July 13, 2021)
  • K192547 — MAGLUMI 2000 HCG/ß-HCG (January 17, 2020)
  • K192790 — Atellica IM Total hCG (ThCG) (October 30, 2019)

FDA data resources