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FDA 510(k)

GENERIC PREGNANCY TEST

K-Number: K823109 · 1982-11-10

ApplicantDiagnostic Specialties
Decision Date1982-11-10
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENERIC PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Specialties. It received FDA 510(k) clearance on 1982-11-10 under 510(k) number K823109. 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 GENERIC PREGNANCY TEST?

GENERIC PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1982-11-10. The listed applicant is Diagnostic Specialties. The 510(k) number is K823109.

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

GENERIC PREGNANCY TEST received FDA 510(k) clearance on 1982-11-10, under 510(k) number K823109.

Who is the listed applicant for GENERIC PREGNANCY TEST?

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

What is the FDA product code for GENERIC PREGNANCY TEST?

The FDA product code for GENERIC PREGNANCY TEST is LCX.

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Other records listing Diagnostic Specialties 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.

K971458ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KITK941001ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KITK930823PROTEIN-BOUND GLUCOSE ASSAYN KITK922032ENZIP URINARY MICROALBUMIN TESTK831180PREGNA-CERT, SLIDE PREGNANCY TESTK813608POTASSIUM REAGENT SET

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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

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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