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FDA 510(k)

XACT NEISSERIA

K-Number: K880511 · 1988-08-25

ApplicantAustin Biological Laboratories
Decision Date1988-08-25
Product CodeJSX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

XACT NEISSERIA is the device name listed in this FDA 510(k) record. The listed applicant is Austin Biological Laboratories. It received FDA 510(k) clearance on 1988-08-25 under 510(k) number K880511. 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 XACT NEISSERIA?

XACT NEISSERIA is a medical device that received FDA 510(k) clearance on 1988-08-25. The listed applicant is Austin Biological Laboratories. The 510(k) number is K880511.

When did XACT NEISSERIA receive FDA 510(k) clearance?

XACT NEISSERIA received FDA 510(k) clearance on 1988-08-25, under 510(k) number K880511.

Who is the listed applicant for XACT NEISSERIA?

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

What is the FDA product code for XACT NEISSERIA?

The FDA product code for XACT NEISSERIA is JSX.

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Other records listing Austin Biological Laboratories 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.

K874727PRECEPT(TM) CIPROFLOXACINK870769AUSTIN NONFERMENTER KITK864069PRECEPT (TM) TICARCILLIN/CLAVULANIC ACIDK862446PRECEPT CEFTAZIDIMEK862560PRECEPT CEFTIZOXIMEK860194AUSTIN ENTERIC SYSTEM

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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.

K960759GONOPOX TEST KITMedtex Laboratories, Inc.K923566NIZYME TEST KITRemel Co.K913456VISI-NEISSERIAKev Connecticut Diagnostics, Inc.K881501MODIFIED IDS RAPID NH SYSTEMInnovative Diagnostic Systems, Inc.K870117NEISSERIA/BRANHAMELLA DIFFERENTIAL TESTPro-Lab, Inc.K853544QUAD FERM +Analytical Products, 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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