FDA 510(k)

FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)

K-Number: K083716 · 2009-06-08

Decision Date2009-06-08

Product CodeLCX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) is the device name listed in this FDA 510(k) record. The listed applicant is Church & Dwight Co., Inc.. It received FDA 510(k) clearance on 2009-06-08 under 510(k) number K083716. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)?

FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) is a medical device that received FDA 510(k) clearance on 2009-06-08. The listed applicant is Church & Dwight Co., Inc.. The 510(k) number is K083716.

When did FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) receive FDA 510(k) clearance?

FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) received FDA 510(k) clearance on 2009-06-08, under 510(k) number K083716.

Who is the listed applicant for FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)?

The FDA 510(k) record lists Church & Dwight Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC)?

The FDA product code for FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) is LCX.

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Official Source

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