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FDA 510(k)

EVATEST STRIP

K-Number: K936013 · 1994-02-25

ApplicantBoehringer Mannheim Italia Spa
Decision Date1994-02-25
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EVATEST STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Italia Spa. It received FDA 510(k) clearance on 1994-02-25 under 510(k) number K936013. 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 EVATEST STRIP?

EVATEST STRIP is a medical device that received FDA 510(k) clearance on 1994-02-25. The listed applicant is Boehringer Mannheim Italia Spa. The 510(k) number is K936013.

When did EVATEST STRIP receive FDA 510(k) clearance?

EVATEST STRIP received FDA 510(k) clearance on 1994-02-25, under 510(k) number K936013.

Who is the listed applicant for EVATEST STRIP?

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

What is the FDA product code for EVATEST STRIP?

The FDA product code for EVATEST STRIP is LCX.

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Other records listing Boehringer Mannheim Italia Spa 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.

K955266ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENTK935502EVENT TEST STRIP HCG

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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