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FDA 510(k)

HSV BIO-BEAD TITRATION KIT

K-Number: K801721 · 1980-09-16

ApplicantLitton Bionetics
Decision Date1980-09-16
Product CodeGQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HSV BIO-BEAD TITRATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Litton Bionetics. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K801721. 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 BIO-BEAD TITRATION KIT?

HSV BIO-BEAD TITRATION KIT is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Litton Bionetics. The 510(k) number is K801721.

When did HSV BIO-BEAD TITRATION KIT receive FDA 510(k) clearance?

HSV BIO-BEAD TITRATION KIT received FDA 510(k) clearance on 1980-09-16, under 510(k) number K801721.

Who is the listed applicant for HSV BIO-BEAD TITRATION KIT?

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

What is the FDA product code for HSV BIO-BEAD TITRATION KIT?

The FDA product code for HSV BIO-BEAD TITRATION KIT is GQN.

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Other records listing Litton Bionetics 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.

K840417EBNA ACIF KITK834443ROTAVIRUS BIO-ENZABEAD SCREEN KITK831343CMV RQ BIO-ENZABEAD KITK822985EBV-M KITK821804RUBELLA RQ BIO-ENZABEAD KITK801720TOXO BIO-BEAD TITRATION KIT

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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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