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FDA 510(k)

ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY

K-Number: K940005 · 1994-03-03

ApplicantBio-Rad Laboratories, Inc.
Decision Date1994-03-03
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 1994-03-03 under 510(k) number K940005. The device is classified under product code CGJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY?

ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY is a medical device that received FDA 510(k) clearance on 1994-03-03. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K940005.

When did ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY receive FDA 510(k) clearance?

ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY received FDA 510(k) clearance on 1994-03-03, under 510(k) number K940005.

Who is the listed applicant for ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY?

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

What is the FDA product code for ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY?

The FDA product code for ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY is CGJ.

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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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