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FDA 510(k)

PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS

K-Number: K872862 · 1987-09-18

ApplicantSerono Diagnostics, Inc.
Decision Date1987-09-18
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS is the device name listed in this FDA 510(k) record. The listed applicant is Serono Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-09-18 under 510(k) number K872862. The device is classified under product code CFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS?

PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS is a medical device that received FDA 510(k) clearance on 1987-09-18. The listed applicant is Serono Diagnostics, Inc.. The 510(k) number is K872862.

When did PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS receive FDA 510(k) clearance?

PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS received FDA 510(k) clearance on 1987-09-18, under 510(k) number K872862.

Who is the listed applicant for PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS?

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

What is the FDA product code for PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS?

The FDA product code for PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS is CFT.

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Other records listing Serono Diagnostics, Inc. as applicant

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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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