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FDA 510(k)

CORDIA HS ANTIBODY TYPING REAGENTS

K-Number: K843751 · 1985-04-24

ApplicantCordis Corp.
Decision Date1985-04-24
Product CodeGQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CORDIA HS ANTIBODY TYPING REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1985-04-24 under 510(k) number K843751. The device is classified under product code GQN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORDIA HS ANTIBODY TYPING REAGENTS?

CORDIA HS ANTIBODY TYPING REAGENTS is a medical device that received FDA 510(k) clearance on 1985-04-24. The listed applicant is Cordis Corp.. The 510(k) number is K843751.

When did CORDIA HS ANTIBODY TYPING REAGENTS receive FDA 510(k) clearance?

CORDIA HS ANTIBODY TYPING REAGENTS received FDA 510(k) clearance on 1985-04-24, under 510(k) number K843751.

Who is the listed applicant for CORDIA HS ANTIBODY TYPING REAGENTS?

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

What is the FDA product code for CORDIA HS ANTIBODY TYPING REAGENTS?

The FDA product code for CORDIA HS ANTIBODY TYPING REAGENTS is GQN.

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Other records listing Cordis Corp. as applicant

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Related Devices (Code: GQN)

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K070265DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000Diagnostic Hybrids, Inc.K063798DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000Diagnostic Hybrids, Inc.K991880LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAYLight DiagnosticsK971662ELVIS HSV ID/TYPING TEST SYSTEMDiagnostic Hybrids, Inc.K971101HSV-2 ANTIGEN CONTROL SLIDESViral Antigens, Inc.K964874HSV-1 ANTIGEN CONTROL SLIDESViral Antigens, 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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