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FDA 510(k)

OREIA II B-HCG PREGNANCY TEST KIT

K-Number: K841525 · 1984-06-05

ApplicantOrganon, Inc.
Decision Date1984-06-05
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OREIA II B-HCG PREGNANCY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Organon, Inc.. It received FDA 510(k) clearance on 1984-06-05 under 510(k) number K841525. 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 OREIA II B-HCG PREGNANCY TEST KIT?

OREIA II B-HCG PREGNANCY TEST KIT is a medical device that received FDA 510(k) clearance on 1984-06-05. The listed applicant is Organon, Inc.. The 510(k) number is K841525.

When did OREIA II B-HCG PREGNANCY TEST KIT receive FDA 510(k) clearance?

OREIA II B-HCG PREGNANCY TEST KIT received FDA 510(k) clearance on 1984-06-05, under 510(k) number K841525.

Who is the listed applicant for OREIA II B-HCG PREGNANCY TEST KIT?

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

What is the FDA product code for OREIA II B-HCG PREGNANCY TEST KIT?

The FDA product code for OREIA II B-HCG PREGNANCY TEST KIT is JHI.

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Other records listing Organon, 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.

K950861RECONSTITUTION ACCESSOREISK853388MONOSTICON UNI-DOTK842314DUOCLON COLOR-CEPTK841602ACCURATE BETA 30 PREGNANCY TEST KITK840650B-NEOCEPT 30K832801OREIA II B-HCG, ENZYME INNUNOASSAY

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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

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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