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FDA 510(k)

NORMAL GLOBULIN REAGENT

K-Number: K792697 · 1980-01-24

ApplicantMeridian Diagnostics, Inc.
Decision Date1980-01-24
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

NORMAL GLOBULIN REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Diagnostics, Inc.. It received FDA 510(k) clearance on 1980-01-24 under 510(k) number K792697. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORMAL GLOBULIN REAGENT?

NORMAL GLOBULIN REAGENT is a medical device that received FDA 510(k) clearance on 1980-01-24. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K792697.

When did NORMAL GLOBULIN REAGENT receive FDA 510(k) clearance?

NORMAL GLOBULIN REAGENT received FDA 510(k) clearance on 1980-01-24, under 510(k) number K792697.

Who is the listed applicant for NORMAL GLOBULIN REAGENT?

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

What is the FDA product code for NORMAL GLOBULIN REAGENT?

The FDA product code for NORMAL GLOBULIN REAGENT is DHR.

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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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