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FDA 510(k)

RADIOIMMUNOASSAY, HUMAN CHORRIONIC

K-Number: K822840 · 1982-10-27

ApplicantBioclinical Group
Decision Date1982-10-27
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RADIOIMMUNOASSAY, HUMAN CHORRIONIC is the device name listed in this FDA 510(k) record. The listed applicant is Bioclinical Group. It received FDA 510(k) clearance on 1982-10-27 under 510(k) number K822840. 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 RADIOIMMUNOASSAY, HUMAN CHORRIONIC?

RADIOIMMUNOASSAY, HUMAN CHORRIONIC is a medical device that received FDA 510(k) clearance on 1982-10-27. The listed applicant is Bioclinical Group. The 510(k) number is K822840.

When did RADIOIMMUNOASSAY, HUMAN CHORRIONIC receive FDA 510(k) clearance?

RADIOIMMUNOASSAY, HUMAN CHORRIONIC received FDA 510(k) clearance on 1982-10-27, under 510(k) number K822840.

Who is the listed applicant for RADIOIMMUNOASSAY, HUMAN CHORRIONIC?

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 RADIOIMMUNOASSAY, HUMAN CHORRIONIC?

The FDA product code for RADIOIMMUNOASSAY, HUMAN CHORRIONIC is JHI.

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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 KITK823005BIO MAG FREE T4 RADIOIMMUNOASSAY KITK823004BIO MAG TOTAL T4 RADIOIMMUNOASSAY KITK822515B-HCG RADIOIMMUNOASSAY 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.

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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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