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FDA 510(k)

ANSWER

K-Number: K852274 · 1985-06-28

ApplicantArmkel, LLC
Decision Date1985-06-28
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANSWER is the device name listed in this FDA 510(k) record. The listed applicant is Armkel, LLC. It received FDA 510(k) clearance on 1985-06-28 under 510(k) number K852274. 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 ANSWER?

ANSWER is a medical device that received FDA 510(k) clearance on 1985-06-28. The listed applicant is Armkel, LLC. The 510(k) number is K852274.

When did ANSWER receive FDA 510(k) clearance?

ANSWER received FDA 510(k) clearance on 1985-06-28, under 510(k) number K852274.

Who is the listed applicant for ANSWER?

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

What is the FDA product code for ANSWER?

The FDA product code for ANSWER is LCX.

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Related Devices (Code: LCX)

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K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestGuangzhou Decheng Biotechnology Co., Ltd.K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd.K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLCK242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test MidstreamNanjing Synthgene Medical Technology Co., Ltd.K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamAssure Tech., LLCK241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.

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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