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FDA 510(k)

BILE AESCULIN DISCS

K-Number: K832306 · 1983-08-24

ApplicantOxoid U.S.A., Inc.
Decision Date1983-08-24
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BILE AESCULIN DISCS is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid U.S.A., Inc.. It received FDA 510(k) clearance on 1983-08-24 under 510(k) number K832306. 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 BILE AESCULIN DISCS?

BILE AESCULIN DISCS is a medical device that received FDA 510(k) clearance on 1983-08-24. The listed applicant is Oxoid U.S.A., Inc.. The 510(k) number is K832306.

When did BILE AESCULIN DISCS receive FDA 510(k) clearance?

BILE AESCULIN DISCS received FDA 510(k) clearance on 1983-08-24, under 510(k) number K832306.

Who is the listed applicant for BILE AESCULIN DISCS?

The FDA 510(k) record lists Oxoid U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BILE AESCULIN DISCS?

The FDA product code for BILE AESCULIN DISCS is JTO.

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Other records listing Oxoid U.S.A., Inc. as applicant

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Related Devices (Code: JTO)

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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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