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FDA 510(k)

RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO

K-Number: K844767 · 1985-02-01

ApplicantBiotecx Laboratories, Inc.
Decision Date1985-02-01
Product CodeCGI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO is the device name listed in this FDA 510(k) record. The listed applicant is Biotecx Laboratories, Inc.. It received FDA 510(k) clearance on 1985-02-01 under 510(k) number K844767. The device is classified under product code CGI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO?

RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO is a medical device that received FDA 510(k) clearance on 1985-02-01. The listed applicant is Biotecx Laboratories, Inc.. The 510(k) number is K844767.

When did RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO receive FDA 510(k) clearance?

RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO received FDA 510(k) clearance on 1985-02-01, under 510(k) number K844767.

Who is the listed applicant for RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO?

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

What is the FDA product code for RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO?

The FDA product code for RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO is CGI.

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Related Devices (Code: CGI)

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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