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FDA 510(k)

CYTOMEGALOVIRUS CONTROL SLIDES

K-Number: K873114 · 1987-09-25

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1987-09-25
Product CodeGQH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CYTOMEGALOVIRUS CONTROL SLIDES is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1987-09-25 under 510(k) number K873114. The device is classified under product code GQH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOMEGALOVIRUS CONTROL SLIDES?

CYTOMEGALOVIRUS CONTROL SLIDES is a medical device that received FDA 510(k) clearance on 1987-09-25. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K873114.

When did CYTOMEGALOVIRUS CONTROL SLIDES receive FDA 510(k) clearance?

CYTOMEGALOVIRUS CONTROL SLIDES received FDA 510(k) clearance on 1987-09-25, under 510(k) number K873114.

Who is the listed applicant for CYTOMEGALOVIRUS CONTROL SLIDES?

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

What is the FDA product code for CYTOMEGALOVIRUS CONTROL SLIDES?

The FDA product code for CYTOMEGALOVIRUS CONTROL SLIDES is GQH.

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Other records listing Medical Diagnostic Technologies, 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.

K062229CTC WORKSTATION, MODEL 2200K972209SPECTROLYSE HEPARIN (ANTI-IIA)K963106CHROMOLIZE PAI-1 KITK960871SPECTROLYSE ANTITHROMBIN III (ANTI-XA)K962489CHROMOLIZE TPA ASSAY KITK960438TINTELIZE PAI-1 KIT

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Related Devices (Code: GQH)

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.

K982311BARTELS CINAKIT CMV ANTIGENEMIAIntracel Corp.K964875CMV ANTIGEN CONTROL SLIDESViral Antigens, Inc.K935809CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAYLight DiagnosticsK882835INDIRECT FLUORESCENT ASSAY FOR (HCMV)Stellar Bio Systems, Inc.K882024FITC MURINE MONOCLONAL ANTI-CMV IGGWhittaker Bioproducts, Inc.K881932ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENTOrtho Diagnostic Systems, 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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