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FDA 510(k)

CYTOTECH CIC ENZYME IMMUNOASSAY

K-Number: K862649 · 1986-09-04

ApplicantCytotech, Inc.
Decision Date1986-09-04
Product CodeDAK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CYTOTECH CIC 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 1986-09-04 under 510(k) number K862649. The device is classified under product code DAK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOTECH CIC ENZYME IMMUNOASSAY?

CYTOTECH CIC ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1986-09-04. The listed applicant is Cytotech, Inc.. The 510(k) number is K862649.

When did CYTOTECH CIC ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

CYTOTECH CIC ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1986-09-04, under 510(k) number K862649.

Who is the listed applicant for CYTOTECH CIC 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 CYTOTECH CIC ENZYME IMMUNOASSAY?

The FDA product code for CYTOTECH CIC ENZYME IMMUNOASSAY is DAK.

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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 CONTROLSK874379CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAYK873249ANTINUCLEAR ANTIBODY (ANA) POSITIVE CONTROLSK872426CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAYK871801CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KITK864315CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAY

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Related Devices (Code: DAK)

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.

K031563BINDAZYME CLQ CIC EIA KITThe Binding Site, Ltd.K032254IBL C1Q-CIC CIA TESTIbl GmbHK012576CIC-C1Q EIAAmerican Laboratory Products Co., Ltd.K973203THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIESSangstat Medical Corp.K972873IMMUSTRIP HAMA IGGImmunomedics, Inc.K951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITKent Laboratories, Inc.

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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