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FDA 510(k)

SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY

K-Number: K894175 · 1989-12-19

ApplicantSerono-Baker Diagnostics, Inc.
Decision Date1989-12-19
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Serono-Baker Diagnostics, Inc.. It received FDA 510(k) clearance on 1989-12-19 under 510(k) number K894175. 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 SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY?

SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY is a medical device that received FDA 510(k) clearance on 1989-12-19. The listed applicant is Serono-Baker Diagnostics, Inc.. The 510(k) number is K894175.

When did SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY receive FDA 510(k) clearance?

SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY received FDA 510(k) clearance on 1989-12-19, under 510(k) number K894175.

Who is the listed applicant for SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY?

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

What is the FDA product code for SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY?

The FDA product code for SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY is JHI.

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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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