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FDA 510(k)

PERFECTA PREGNANCY TEST

K-Number: K965184 · 1997-02-04

ApplicantWyntek Diagnostics, Inc.
Decision Date1997-02-04
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PERFECTA PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Wyntek Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-02-04 under 510(k) number K965184. 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 PERFECTA PREGNANCY TEST?

PERFECTA PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1997-02-04. The listed applicant is Wyntek Diagnostics, Inc.. The 510(k) number is K965184.

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

PERFECTA PREGNANCY TEST received FDA 510(k) clearance on 1997-02-04, under 510(k) number K965184.

Who is the listed applicant for PERFECTA PREGNANCY TEST?

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

What is the FDA product code for PERFECTA PREGNANCY TEST?

The FDA product code for PERFECTA PREGNANCY TEST is LCX.

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Other records listing Wyntek Diagnostics, 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.

K992658OSOM ULTRA STREP A TEST, MODEL 147K990578OSOM CARD II HCG-URINE TEST, MODEL 102K990576OSOM CARD PREGNANCY TEST, MODEL 103K974159OSOM HCG-URINE TEST MODEL 101K973879OSOM CARD HCG-URINE TESTK972231OSOM MONO TEST 143

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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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