Azog, Inc. HCG One-Step Urine Pregnancy Test Strip (Dipstick)

FDA 510(k) K022680 · Azog, Inc.

Substantially Equivalent

510(k) numberK022680

Submission

Device name
Azog, Inc. HCG One-Step Urine Pregnancy Test Strip (Dipstick)
Applicant
Azog, Inc.
Phillipsburg, NJ, US
Received
August 12, 2002
Decision date
November 1, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DHA – System, Test, Human Chorionic Gonadotropin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1155
Specialty
Clinical Chemistry

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K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800…DHA · Traditional Diazyme Laboratories, Inc.12/13/2021SE
K203227Elecsys HCG STATDHA · Traditional Roche Diagnostics08/18/2021SE
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More from Siemens Healthcare Diagnostics, Inc.

510(k)DeviceDecision
K041748Azog, Inc. HCG One-Step Urine Home Pregnancy Test (Dip Stick, Cassette and Midstream)LCX · Abbreviated 08/09/2004SE
K022681Azog, Inc. HCG One-Step Urine Pregnancy Test (Device or Cassette)DHA · Traditional 11/01/2002SE

Questions and answers

When was Azog, Inc. HCG One-Step Urine Pregnancy Test Strip (Dipstick) cleared by the FDA?

Azog, Inc. HCG One-Step Urine Pregnancy Test Strip (Dipstick) (K022680) received a 510(k) decision of Substantially Equivalent on November 1, 2002, 81 days after the submission was received.

What is the product code of K022680?

The FDA product code is DHA – System, Test, Human Chorionic Gonadotropin, a Class II (moderate risk) device regulated under 21 CFR 862.1155.