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FDA 510(k)

CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY

K-Number: K874379 · 1987-11-25

ApplicantCytotech, Inc.
Decision Date1987-11-25
Product CodeCZY
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Cytotech, Inc.. It received FDA 510(k) clearance on 1987-11-25 under 510(k) number K874379. The device is classified under product code CZY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY?

CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1987-11-25. The listed applicant is Cytotech, Inc.. The 510(k) number is K874379.

When did CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1987-11-25, under 510(k) number K874379.

Who is the listed applicant for CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY?

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

What is the FDA product code for CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY?

The FDA product code for CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY is CZY.

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Other records listing Cytotech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K882829CIRCULATING IMMUNE COMPLEXES CONTROLSK873249ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLSK872426CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAYK871801CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KITK864315CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAYK862838CYTOTECH HSV IGG ENZYME IMMUNOASSAY

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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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