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FDA 510(k)

PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT

K-Number: K896482 · 1990-03-06

ApplicantPacific Biotech, Inc.
Decision Date1990-03-06
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Biotech, Inc.. It received FDA 510(k) clearance on 1990-03-06 under 510(k) number K896482. 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 PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT?

PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT is a medical device that received FDA 510(k) clearance on 1990-03-06. The listed applicant is Pacific Biotech, Inc.. The 510(k) number is K896482.

When did PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT receive FDA 510(k) clearance?

PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT received FDA 510(k) clearance on 1990-03-06, under 510(k) number K896482.

Who is the listed applicant for PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT?

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

What is the FDA product code for PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT?

The FDA product code for PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT is LCX.

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Other records listing Pacific Biotech, 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.

K924461STREP A NEGATIVE CONTROLK902510CARDS O.S. MONOK896221CARDS O.S.(TM) STREP AK895390CARDS O.S. (TM) HCG-URINEK891770HCG IRMA IIK884616FIRSTDAY EARLY PREGNANCY TESTING KIT II

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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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