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FDA 510(k)

INSURE PREGNANCY TEST

K-Number: K991515 · 1999-05-28

ApplicantInbios Intl., Inc.
Decision Date1999-05-28
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INSURE PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Inbios Intl., Inc.. It received FDA 510(k) clearance on 1999-05-28 under 510(k) number K991515. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSURE PREGNANCY TEST?

INSURE PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1999-05-28. The listed applicant is Inbios Intl., Inc.. The 510(k) number is K991515.

When did INSURE PREGNANCY TEST receive FDA 510(k) clearance?

INSURE PREGNANCY TEST received FDA 510(k) clearance on 1999-05-28, under 510(k) number K991515.

Who is the listed applicant for INSURE PREGNANCY TEST?

The FDA 510(k) record lists Inbios Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INSURE PREGNANCY TEST?

The FDA product code for INSURE PREGNANCY TEST is DHA.

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Other records listing Inbios Intl., Inc. as applicant

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Related Devices (Code: DHA)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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