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FDA 510(k)

ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE

K-Number: K864966 · 1987-01-09

ApplicantDiagnostics Biochem Canada, Inc.
Decision Date1987-01-09
Product CodeCGF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostics Biochem Canada, Inc.. It received FDA 510(k) clearance on 1987-01-09 under 510(k) number K864966. The device is classified under product code CGF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE?

ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE is a medical device that received FDA 510(k) clearance on 1987-01-09. The listed applicant is Diagnostics Biochem Canada, Inc.. The 510(k) number is K864966.

When did ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE receive FDA 510(k) clearance?

ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE received FDA 510(k) clearance on 1987-01-09, under 510(k) number K864966.

Who is the listed applicant for ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE?

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

What is the FDA product code for ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE?

The FDA product code for ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE is CGF.

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Other records listing Diagnostics Biochem Canada, Inc. as applicant

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K030730FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KITK014120TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)K832297HYDROXYPROGESTERONE-17K801729ANDROSTENEDIONE RADIOIMMUNOASSAY KITK781310HUMAN CHORIONIC GONADO.-BETA RIA KIT

Related Devices (Code: CGF)

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.

K970915DSL ESTRONE-SULFATE RIADiagnostic Systems Laboratories, Inc.K935013DSL ESTRONE (DSL 8700)Diagnostic Systems Laboratories, Inc.K833406IMMOPHASE D-TE 3 RADIOIMMUNOASSAYCorning Medical & Scientific

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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