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FDA 510(k)

QUICK CARD HCG ONE STEP PREGNANCY TEST

K-Number: K973570 · 1997-10-31

ApplicantPhamatech
Decision Date1997-10-31
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUICK CARD HCG ONE STEP PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Phamatech. It received FDA 510(k) clearance on 1997-10-31 under 510(k) number K973570. 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 QUICK CARD HCG ONE STEP PREGNANCY TEST?

QUICK CARD HCG ONE STEP PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1997-10-31. The listed applicant is Phamatech. The 510(k) number is K973570.

When did QUICK CARD HCG ONE STEP PREGNANCY TEST receive FDA 510(k) clearance?

QUICK CARD HCG ONE STEP PREGNANCY TEST received FDA 510(k) clearance on 1997-10-31, under 510(k) number K973570.

Who is the listed applicant for QUICK CARD HCG ONE STEP PREGNANCY TEST?

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

What is the FDA product code for QUICK CARD HCG ONE STEP PREGNANCY TEST?

The FDA product code for QUICK CARD HCG ONE STEP PREGNANCY TEST is LCX.

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Other records listing Phamatech 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.

K041578QUICKSCREEN, MODELS 9177X AND 9178XK030447AT HOME DRUG CUP, MODEL 9150XK010833AT WORK DRUG TEST, MODEL 9177T AWTK010836AT WORK DRUG TEST, MODEL 9147T AWTK010655AT HOME DRUG TESTT, MODEL 9150 TK010653AT HOME DRUG TEST, MODEL 9068 T

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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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