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FDA 510(k)

ANI BIOCARD(TM) HCG TEST

K-Number: K933794 · 1994-05-19

ApplicantCanadian Bioclinical, Ltd.
Decision Date1994-05-19
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ANI BIOCARD(TM) HCG TEST is the device name listed in this FDA 510(k) record. The listed applicant is Canadian Bioclinical, Ltd.. It received FDA 510(k) clearance on 1994-05-19 under 510(k) number K933794. 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 ANI BIOCARD(TM) HCG TEST?

ANI BIOCARD(TM) HCG TEST is a medical device that received FDA 510(k) clearance on 1994-05-19. The listed applicant is Canadian Bioclinical, Ltd.. The 510(k) number is K933794.

When did ANI BIOCARD(TM) HCG TEST receive FDA 510(k) clearance?

ANI BIOCARD(TM) HCG TEST received FDA 510(k) clearance on 1994-05-19, under 510(k) number K933794.

Who is the listed applicant for ANI BIOCARD(TM) HCG TEST?

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

What is the FDA product code for ANI BIOCARD(TM) HCG TEST?

The FDA product code for ANI BIOCARD(TM) HCG TEST is LCX.

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Other records listing Canadian Bioclinical, Ltd. as applicant

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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

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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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