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FDA 510(k)

RIM - NITRATE TEST

K-Number: K841270 · 1984-04-20

ApplicantAustin Biological Laboratories
Decision Date1984-04-20
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RIM - NITRATE TEST 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 1984-04-20 under 510(k) number K841270. 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 RIM - NITRATE TEST?

RIM - NITRATE TEST is a medical device that received FDA 510(k) clearance on 1984-04-20. The listed applicant is Austin Biological Laboratories. The 510(k) number is K841270.

When did RIM - NITRATE TEST receive FDA 510(k) clearance?

RIM - NITRATE TEST received FDA 510(k) clearance on 1984-04-20, under 510(k) number K841270.

Who is the listed applicant for RIM - NITRATE TEST?

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 RIM - NITRATE TEST?

The FDA product code for RIM - NITRATE TEST 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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