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FDA 510(k)

ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT

K-Number: K871308 · 1987-06-11

ApplicantAllelix, Inc.
Decision Date1987-06-11
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Allelix, Inc.. It received FDA 510(k) clearance on 1987-06-11 under 510(k) number K871308. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT?

ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT is a medical device that received FDA 510(k) clearance on 1987-06-11. The listed applicant is Allelix, Inc.. The 510(k) number is K871308.

When did ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT receive FDA 510(k) clearance?

ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT received FDA 510(k) clearance on 1987-06-11, under 510(k) number K871308.

Who is the listed applicant for ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT?

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

What is the FDA product code for ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT?

The FDA product code for ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT is JHI.

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Other records listing Allelix, 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.

K871620ALLELIX GROUP A STREPTOCOCCUS DETECTION KIT

Related Devices (Code: JHI)

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.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. 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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