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FDA 510(k)

QUALITATIVE ENZYME IMMUNOASSAY-DETECT

K-Number: K832905 · 1984-02-03

ApplicantBtc Diagnostics, Inc.
Decision Date1984-02-03
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUALITATIVE ENZYME IMMUNOASSAY-DETECT is the device name listed in this FDA 510(k) record. The listed applicant is Btc Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-02-03 under 510(k) number K832905. 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 QUALITATIVE ENZYME IMMUNOASSAY-DETECT?

QUALITATIVE ENZYME IMMUNOASSAY-DETECT is a medical device that received FDA 510(k) clearance on 1984-02-03. The listed applicant is Btc Diagnostics, Inc.. The 510(k) number is K832905.

When did QUALITATIVE ENZYME IMMUNOASSAY-DETECT receive FDA 510(k) clearance?

QUALITATIVE ENZYME IMMUNOASSAY-DETECT received FDA 510(k) clearance on 1984-02-03, under 510(k) number K832905.

Who is the listed applicant for QUALITATIVE ENZYME IMMUNOASSAY-DETECT?

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

What is the FDA product code for QUALITATIVE ENZYME IMMUNOASSAY-DETECT?

The FDA product code for QUALITATIVE ENZYME IMMUNOASSAY-DETECT is LCX.

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Other records listing Btc 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.

K841545ENZYME IMMUNOASSAY FOR DETECTION HORMK833710BTC URINE LH ASSAYK831604HCG ACCU-STICKK831125BTC URINE LCG ASSAY

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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