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FDA 510(k)

CIRCULATING IMMUNE COMPLEXES CONTROLS

K-Number: K882829 · 1988-08-04

ApplicantCytotech, Inc.
Decision Date1988-08-04
Product CodeDAK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CIRCULATING IMMUNE COMPLEXES CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Cytotech, Inc.. It received FDA 510(k) clearance on 1988-08-04 under 510(k) number K882829. 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 CIRCULATING IMMUNE COMPLEXES CONTROLS?

CIRCULATING IMMUNE COMPLEXES CONTROLS is a medical device that received FDA 510(k) clearance on 1988-08-04. The listed applicant is Cytotech, Inc.. The 510(k) number is K882829.

When did CIRCULATING IMMUNE COMPLEXES CONTROLS receive FDA 510(k) clearance?

CIRCULATING IMMUNE COMPLEXES CONTROLS received FDA 510(k) clearance on 1988-08-04, under 510(k) number K882829.

Who is the listed applicant for CIRCULATING IMMUNE COMPLEXES CONTROLS?

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 CIRCULATING IMMUNE COMPLEXES CONTROLS?

The FDA product code for CIRCULATING IMMUNE COMPLEXES CONTROLS 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.

K874379CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAYK873249ANTINUCLEAR 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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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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