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FDA 510(k)

IMMUNOCORP COATED TUBE IRMA HCG

K-Number: K910349 · 1991-03-21

ApplicantImmunocorp
Decision Date1991-03-21
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMUNOCORP COATED TUBE IRMA HCG is the device name listed in this FDA 510(k) record. The listed applicant is Immunocorp. It received FDA 510(k) clearance on 1991-03-21 under 510(k) number K910349. 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 IMMUNOCORP COATED TUBE IRMA HCG?

IMMUNOCORP COATED TUBE IRMA HCG is a medical device that received FDA 510(k) clearance on 1991-03-21. The listed applicant is Immunocorp. The 510(k) number is K910349.

When did IMMUNOCORP COATED TUBE IRMA HCG receive FDA 510(k) clearance?

IMMUNOCORP COATED TUBE IRMA HCG received FDA 510(k) clearance on 1991-03-21, under 510(k) number K910349.

Who is the listed applicant for IMMUNOCORP COATED TUBE IRMA HCG?

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

What is the FDA product code for IMMUNOCORP COATED TUBE IRMA HCG?

The FDA product code for IMMUNOCORP COATED TUBE IRMA HCG is JHI.

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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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