Insure Pregnancy Test

FDA 510(k) K991515 · Inbios Intl., Inc.

Substantially Equivalent

510(k) numberK991515

Submission

Device name
Insure Pregnancy Test
Applicant
Inbios Intl., Inc.
Seattle, WA, US
Received
April 30, 1999
Decision date
May 28, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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Questions and answers

When was Insure Pregnancy Test cleared by the FDA?

Insure Pregnancy Test (K991515) received a 510(k) decision of Substantially Equivalent on May 28, 1999, 28 days after the submission was received.

What is the product code of K991515?

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