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FDA 510(k)

SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA

K-Number: K862439 · 1986-08-19

ApplicantBoots-Celltech Diagnostics, Inc.
Decision Date1986-08-19
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA is the device name listed in this FDA 510(k) record. The listed applicant is Boots-Celltech Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-08-19 under 510(k) number K862439. 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 SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA?

SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA is a medical device that received FDA 510(k) clearance on 1986-08-19. The listed applicant is Boots-Celltech Diagnostics, Inc.. The 510(k) number is K862439.

When did SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA receive FDA 510(k) clearance?

SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA received FDA 510(k) clearance on 1986-08-19, under 510(k) number K862439.

Who is the listed applicant for SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA?

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

What is the FDA product code for SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA?

The FDA product code for SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA is CGJ.

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Related Devices (Code: CGJ)

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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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