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FDA 510(k)

PREGNANCY TEST KIT, OVER-THE-COUNTER

K-Number: K780321 · 1978-04-04

ApplicantIntl. Diagnostic, Inc.
Decision Date1978-04-04
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PREGNANCY TEST KIT, OVER-THE-COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Diagnostic, Inc.. It received FDA 510(k) clearance on 1978-04-04 under 510(k) number K780321. 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 PREGNANCY TEST KIT, OVER-THE-COUNTER?

PREGNANCY TEST KIT, OVER-THE-COUNTER is a medical device that received FDA 510(k) clearance on 1978-04-04. The listed applicant is Intl. Diagnostic, Inc.. The 510(k) number is K780321.

When did PREGNANCY TEST KIT, OVER-THE-COUNTER receive FDA 510(k) clearance?

PREGNANCY TEST KIT, OVER-THE-COUNTER received FDA 510(k) clearance on 1978-04-04, under 510(k) number K780321.

Who is the listed applicant for PREGNANCY TEST KIT, OVER-THE-COUNTER?

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

What is the FDA product code for PREGNANCY TEST KIT, OVER-THE-COUNTER?

The FDA product code for PREGNANCY TEST KIT, OVER-THE-COUNTER is LCX.

Related Clinical Trials

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Other records listing Intl. Diagnostic, Inc. as applicant

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.

K841853PREG-BETA ONE HOUR TUBE TESTK840833PREG BETA BLUS SLIDEK834584NABI CRP-Q.S. TESTK840005NABI RF-Q.S. TESTK802343PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO

Related Devices (Code: LCX)

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.

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

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

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