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FDA 510(k)

IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF

K-Number: K842830 · 1985-11-26

ApplicantBartels Immunodiagnostic Supplies, Inc.
Decision Date1985-11-26
Product CodeGQN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF is the device name listed in this FDA 510(k) record. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. It received FDA 510(k) clearance on 1985-11-26 under 510(k) number K842830. The device is classified under product code GQN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF?

IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF is a medical device that received FDA 510(k) clearance on 1985-11-26. The listed applicant is Bartels Immunodiagnostic Supplies, Inc.. The 510(k) number is K842830.

When did IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF receive FDA 510(k) clearance?

IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF received FDA 510(k) clearance on 1985-11-26, under 510(k) number K842830.

Who is the listed applicant for IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF?

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

What is the FDA product code for IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF?

The FDA product code for IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF is GQN.

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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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