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FDA 510(k)

HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT

K-Number: K911345 · 1991-06-17

ApplicantDiagnostic Hybrids, Inc.
Decision Date1991-06-17
Product CodeGQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Hybrids, Inc.. It received FDA 510(k) clearance on 1991-06-17 under 510(k) number K911345. 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 HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT?

HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT is a medical device that received FDA 510(k) clearance on 1991-06-17. The listed applicant is Diagnostic Hybrids, Inc.. The 510(k) number is K911345.

When did HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT receive FDA 510(k) clearance?

HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT received FDA 510(k) clearance on 1991-06-17, under 510(k) number K911345.

Who is the listed applicant for HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT?

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

What is the FDA product code for HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT?

The FDA product code for HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT is GQN.

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Other records listing Diagnostic Hybrids, 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.

K092229THYRETAIN TM TSI REPORTER BIOASSAYK093415D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KITK093233D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KITK092882D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KITK091171D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KITK091753ELVIS HSV ID AND D3 TYPING TEST SYSTEM

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Related Devices (Code: GQN)

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.

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.K964874HSV-1 ANTIGEN CONTROL SLIDESViral Antigens, Inc.K971101HSV-2 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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