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FDA 510(k)

SPOTTEST OXIDASE REAGENT

K-Number: K840575 · 1984-02-27

ApplicantDifco Laboratories, Inc.
Decision Date1984-02-27
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SPOTTEST OXIDASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Difco Laboratories, Inc.. It received FDA 510(k) clearance on 1984-02-27 under 510(k) number K840575. 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 SPOTTEST OXIDASE REAGENT?

SPOTTEST OXIDASE REAGENT is a medical device that received FDA 510(k) clearance on 1984-02-27. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K840575.

When did SPOTTEST OXIDASE REAGENT receive FDA 510(k) clearance?

SPOTTEST OXIDASE REAGENT received FDA 510(k) clearance on 1984-02-27, under 510(k) number K840575.

Who is the listed applicant for SPOTTEST OXIDASE REAGENT?

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

What is the FDA product code for SPOTTEST OXIDASE REAGENT?

The FDA product code for SPOTTEST OXIDASE REAGENT is JTO.

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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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