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FDA 510(k)

STAR HCG MONOCLONAL ANTIBODY IMMUNO

K-Number: K842598 · 1984-07-26

ApplicantSyncor Intl. Corp.
Decision Date1984-07-26
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STAR HCG MONOCLONAL ANTIBODY IMMUNO is the device name listed in this FDA 510(k) record. The listed applicant is Syncor Intl. Corp.. It received FDA 510(k) clearance on 1984-07-26 under 510(k) number K842598. 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 STAR HCG MONOCLONAL ANTIBODY IMMUNO?

STAR HCG MONOCLONAL ANTIBODY IMMUNO is a medical device that received FDA 510(k) clearance on 1984-07-26. The listed applicant is Syncor Intl. Corp.. The 510(k) number is K842598.

When did STAR HCG MONOCLONAL ANTIBODY IMMUNO receive FDA 510(k) clearance?

STAR HCG MONOCLONAL ANTIBODY IMMUNO received FDA 510(k) clearance on 1984-07-26, under 510(k) number K842598.

Who is the listed applicant for STAR HCG MONOCLONAL ANTIBODY IMMUNO?

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

What is the FDA product code for STAR HCG MONOCLONAL ANTIBODY IMMUNO?

The FDA product code for STAR HCG MONOCLONAL ANTIBODY IMMUNO is JHI.

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Other records listing Syncor Intl. Corp. 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.

K945825SECURE SAFETY INSERTK851828IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-CK850433CESIUM 137 ENDOMETRIAL SOURCEK852023CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41K852665SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAYK851033SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT

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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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