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FDA 510(k)

IN VITRO GAMMACOAT B-HCG RADIO. TEST

K-Number: K823313 · 1982-12-22

ApplicantClinical Assays, Inc.
Decision Date1982-12-22
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IN VITRO GAMMACOAT B-HCG RADIO. TEST is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Assays, Inc.. It received FDA 510(k) clearance on 1982-12-22 under 510(k) number K823313. 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 IN VITRO GAMMACOAT B-HCG RADIO. TEST?

IN VITRO GAMMACOAT B-HCG RADIO. TEST is a medical device that received FDA 510(k) clearance on 1982-12-22. The listed applicant is Clinical Assays, Inc.. The 510(k) number is K823313.

When did IN VITRO GAMMACOAT B-HCG RADIO. TEST receive FDA 510(k) clearance?

IN VITRO GAMMACOAT B-HCG RADIO. TEST received FDA 510(k) clearance on 1982-12-22, under 510(k) number K823313.

Who is the listed applicant for IN VITRO GAMMACOAT B-HCG RADIO. TEST?

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

What is the FDA product code for IN VITRO GAMMACOAT B-HCG RADIO. TEST?

The FDA product code for IN VITRO GAMMACOAT B-HCG RADIO. TEST is JHI.

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Other records listing Clinical Assays, Inc. as applicant

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K832711VITAMIN B12 FOLATE CA-1515-125K832710VITAMIN B12 RADIOASSAY KIT CA-1534K832712FOLATE RADIOASSAY KIT CA-1562-125K823476GAMMADAB LH RADIO-KIT #CA-1508K821611GAMMADAB [125] FSH RADIOIMMUNAY KITK821092GAMMADAB[125]EGE RADIOIMMUNOASSAY IT

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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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