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FDA 510(k)

BIO MAG FREE T4 RADIOIMMUNOASSAY KIT

K-Number: K823005 · 1982-12-15

ApplicantBioclinical Group
Decision Date1982-12-15
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIO MAG FREE T4 RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bioclinical Group. It received FDA 510(k) clearance on 1982-12-15 under 510(k) number K823005. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO MAG FREE T4 RADIOIMMUNOASSAY KIT?

BIO MAG FREE T4 RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1982-12-15. The listed applicant is Bioclinical Group. The 510(k) number is K823005.

When did BIO MAG FREE T4 RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

BIO MAG FREE T4 RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1982-12-15, under 510(k) number K823005.

Who is the listed applicant for BIO MAG FREE T4 RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for BIO MAG FREE T4 RADIOIMMUNOASSAY KIT?

The FDA product code for BIO MAG FREE T4 RADIOIMMUNOASSAY KIT is CEC.

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Other records listing Bioclinical Group 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.

K862968FREE T3 RADIOIMMUNOASSAY KITK853837LH/FSH RADIOIMMUNOASSAY KITK832638CORTISOL RADIOIMMUNOASSAY KITK823004BIO MAG TOTAL T4 RADIOIMMUNOASSAY KITK822840RADIOIMMUNOASSAY, HUMAN CHORRIONICK822515B-HCG RADIOIMMUNOASSAY KIT

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Related Devices (Code: CEC)

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.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, Inc.

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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