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FDA 510(k)

RAPID IDENTIFI-METHOD NEISSERIA KIT

K-Number: K830968 · 1983-06-16

ApplicantAustin Biological Laboratories
Decision Date1983-06-16
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPID IDENTIFI-METHOD NEISSERIA KIT 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 1983-06-16 under 510(k) number K830968. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID IDENTIFI-METHOD NEISSERIA KIT?

RAPID IDENTIFI-METHOD NEISSERIA KIT is a medical device that received FDA 510(k) clearance on 1983-06-16. The listed applicant is Austin Biological Laboratories. The 510(k) number is K830968.

When did RAPID IDENTIFI-METHOD NEISSERIA KIT receive FDA 510(k) clearance?

RAPID IDENTIFI-METHOD NEISSERIA KIT received FDA 510(k) clearance on 1983-06-16, under 510(k) number K830968.

Who is the listed applicant for RAPID IDENTIFI-METHOD NEISSERIA KIT?

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 RAPID IDENTIFI-METHOD NEISSERIA KIT?

The FDA product code for RAPID IDENTIFI-METHOD NEISSERIA KIT is JTO.

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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.

K880511XACT NEISSERIAK874727PRECEPT(TM) CIPROFLOXACINK870769AUSTIN NONFERMENTER KITK864069PRECEPT (TM) TICARCILLIN/CLAVULANIC ACIDK862446PRECEPT CEFTAZIDIMEK862560PRECEPT CEFTIZOXIME

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Related Devices (Code: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, 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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