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FDA 510(k)

SR1 (FSH) IMMUNOENZYMETRIC ASSAY

K-Number: K892706 · 1989-06-09

ApplicantSerono-Baker Diagnostics, Inc.
Decision Date1989-06-09
Product CodeCGJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SR1 (FSH) 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 1989-06-09 under 510(k) number K892706. 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 SR1 (FSH) IMMUNOENZYMETRIC ASSAY?

SR1 (FSH) IMMUNOENZYMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1989-06-09. The listed applicant is Serono-Baker Diagnostics, Inc.. The 510(k) number is K892706.

When did SR1 (FSH) IMMUNOENZYMETRIC ASSAY receive FDA 510(k) clearance?

SR1 (FSH) IMMUNOENZYMETRIC ASSAY received FDA 510(k) clearance on 1989-06-09, under 510(k) number K892706.

Who is the listed applicant for SR1 (FSH) 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 SR1 (FSH) IMMUNOENZYMETRIC ASSAY?

The FDA product code for SR1 (FSH) IMMUNOENZYMETRIC ASSAY 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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