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FDA 510(k)

RIA QUANT B-HCG TEST KIT

K-Number: K781578 · 1978-10-10

ApplicantMallinckrodt Critical Care
Decision Date1978-10-10
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIA QUANT B-HCG TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1978-10-10 under 510(k) number K781578. 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 RIA QUANT B-HCG TEST KIT?

RIA QUANT B-HCG TEST KIT is a medical device that received FDA 510(k) clearance on 1978-10-10. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K781578.

When did RIA QUANT B-HCG TEST KIT receive FDA 510(k) clearance?

RIA QUANT B-HCG TEST KIT received FDA 510(k) clearance on 1978-10-10, under 510(k) number K781578.

Who is the listed applicant for RIA QUANT B-HCG TEST KIT?

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

What is the FDA product code for RIA QUANT B-HCG TEST KIT?

The FDA product code for RIA QUANT B-HCG TEST KIT is JHI.

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Other records listing Mallinckrodt Critical Care as applicant

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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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