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FDA 510(k)

HOME PREGNANCY TEST

K-Number: K112315 · 2012-04-23

ApplicantNewscen Coast Bio-Pharmaceutical Co., Ltd.
Decision Date2012-04-23
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HOME PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Newscen Coast Bio-Pharmaceutical Co., Ltd.. It received FDA 510(k) clearance on 2012-04-23 under 510(k) number K112315. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOME PREGNANCY TEST?

HOME PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 2012-04-23. The listed applicant is Newscen Coast Bio-Pharmaceutical Co., Ltd.. The 510(k) number is K112315.

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

HOME PREGNANCY TEST received FDA 510(k) clearance on 2012-04-23, under 510(k) number K112315.

Who is the listed applicant for HOME PREGNANCY TEST?

The FDA 510(k) record lists Newscen Coast Bio-Pharmaceutical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOME PREGNANCY TEST?

The FDA product code for HOME PREGNANCY TEST is JHI.

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Related Devices (Code: JHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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