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FDA 510(k)

SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY

K-Number: K893605 · 1989-06-20

ApplicantSerono-Baker Diagnostics, Inc.
Decision Date1989-06-20
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC 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 1989-06-20 under 510(k) number K893605. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY?

SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1989-06-20. The listed applicant is Serono-Baker Diagnostics, Inc.. The 510(k) number is K893605.

When did SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY receive FDA 510(k) clearance?

SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY received FDA 510(k) clearance on 1989-06-20, under 510(k) number K893605.

Who is the listed applicant for SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC 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 LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY?

The FDA product code for SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY is CEP.

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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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