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FDA 510(k)

SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY

K-Number: K880758 · 1988-04-18

ApplicantBoots-Celltech Diagnostics, Inc.
Decision Date1988-04-18
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY 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 1988-04-18 under 510(k) number K880758. 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 SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY?

SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1988-04-18. The listed applicant is Boots-Celltech Diagnostics, Inc.. The 510(k) number is K880758.

When did SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY receive FDA 510(k) clearance?

SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY received FDA 510(k) clearance on 1988-04-18, under 510(k) number K880758.

Who is the listed applicant for SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY?

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 SPECIFIC IMMUNORADIOMETRIC ASSAY?

The FDA product code for SUCROSEP SPECIFIC IMMUNORADIOMETRIC 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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