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FDA 510(k)

GONOPOX TEST KIT

K-Number: K960759 · 1996-09-18

ApplicantMedtex Laboratories, Inc.
Decision Date1996-09-18
Product CodeJSX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GONOPOX TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medtex Laboratories, Inc.. It received FDA 510(k) clearance on 1996-09-18 under 510(k) number K960759. The device is classified under product code JSX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GONOPOX TEST KIT?

GONOPOX TEST KIT is a medical device that received FDA 510(k) clearance on 1996-09-18. The listed applicant is Medtex Laboratories, Inc.. The 510(k) number is K960759.

When did GONOPOX TEST KIT receive FDA 510(k) clearance?

GONOPOX TEST KIT received FDA 510(k) clearance on 1996-09-18, under 510(k) number K960759.

Who is the listed applicant for GONOPOX TEST KIT?

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

What is the FDA product code for GONOPOX TEST KIT?

The FDA product code for GONOPOX TEST KIT is JSX.

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Related Devices (Code: JSX)

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.

K923566NIZYME TEST KITRemel Co.K913456VISI-NEISSERIAKev Connecticut Diagnostics, Inc.K880511XACT NEISSERIAAustin Biological LaboratoriesK881501MODIFIED IDS RAPID NH SYSTEMInnovative Diagnostic Systems, Inc.K870117NEISSERIA/BRANHAMELLA DIFFERENTIAL TESTPro-Lab, Inc.K853544QUAD FERM +Analytical Products, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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