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FDA 510(k)

CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY

K-Number: K872426 · 1987-07-23

ApplicantCytotech, Inc.
Decision Date1987-07-23
Product CodeDBA
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CYTOTECH C1-INHIBITOR 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 1987-07-23 under 510(k) number K872426. The device is classified under product code DBA. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY?

CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1987-07-23. The listed applicant is Cytotech, Inc.. The 510(k) number is K872426.

When did CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY receive FDA 510(k) clearance?

CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY received FDA 510(k) clearance on 1987-07-23, under 510(k) number K872426.

Who is the listed applicant for CYTOTECH C1-INHIBITOR 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 C1-INHIBITOR ENZYME IMMUNOASSAY?

The FDA product code for CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY is DBA.

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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 CONTROLSK871801CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KITK864315CYTOTECH RUBELLA IGG ENZYME IMMUNOASSAYK862838CYTOTECH HSV IGG ENZYME IMMUNOASSAY

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Related Devices (Code: DBA)

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.

K122304HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUSThe Binding Site Group , Ltd.K072965DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CONDade Behring, Inc.K011780K-ASSAY C1-INAKamiya Biomedical Co.K003747C1-INHIBITOR MICROTITER ASSAY DEVICEBaxter Healthcare CorpK965024N-ASSAY TIA C1-INACTIVATOR TEST KITCrestat Diagnostics, Inc.K960257N ANTISERUM TO C1 INHIBITORBehring Diagnostics, 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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