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FDA 510(k)

ALLO-TYPE HUMAN IMMUNOGLOBULIN-

K-Number: K841114 · 1984-06-14

ApplicantGenetic Testing Institute
Decision Date1984-06-14
Product CodeDGX
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ALLO-TYPE HUMAN IMMUNOGLOBULIN- is the device name listed in this FDA 510(k) record. The listed applicant is Genetic Testing Institute. It received FDA 510(k) clearance on 1984-06-14 under 510(k) number K841114. The device is classified under product code DGX. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLO-TYPE HUMAN IMMUNOGLOBULIN-?

ALLO-TYPE HUMAN IMMUNOGLOBULIN- is a medical device that received FDA 510(k) clearance on 1984-06-14. The listed applicant is Genetic Testing Institute. The 510(k) number is K841114.

When did ALLO-TYPE HUMAN IMMUNOGLOBULIN- receive FDA 510(k) clearance?

ALLO-TYPE HUMAN IMMUNOGLOBULIN- received FDA 510(k) clearance on 1984-06-14, under 510(k) number K841114.

Who is the listed applicant for ALLO-TYPE HUMAN IMMUNOGLOBULIN-?

The FDA 510(k) record lists Genetic Testing Institute as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALLO-TYPE HUMAN IMMUNOGLOBULIN-?

The FDA product code for ALLO-TYPE HUMAN IMMUNOGLOBULIN- is DGX.

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Other records listing Genetic Testing Institute as applicant

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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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