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FDA 510(k)

ANTISERUM TO HUMAN IGG

K-Number: K822669 · 1982-11-17

ApplicantAmico Lab, Inc.
Decision Date1982-11-17
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTISERUM TO HUMAN IGG is the device name listed in this FDA 510(k) record. The listed applicant is Amico Lab, Inc.. It received FDA 510(k) clearance on 1982-11-17 under 510(k) number K822669. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTISERUM TO HUMAN IGG?

ANTISERUM TO HUMAN IGG is a medical device that received FDA 510(k) clearance on 1982-11-17. The listed applicant is Amico Lab, Inc.. The 510(k) number is K822669.

When did ANTISERUM TO HUMAN IGG receive FDA 510(k) clearance?

ANTISERUM TO HUMAN IGG received FDA 510(k) clearance on 1982-11-17, under 510(k) number K822669.

Who is the listed applicant for ANTISERUM TO HUMAN IGG?

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

What is the FDA product code for ANTISERUM TO HUMAN IGG?

The FDA product code for ANTISERUM TO HUMAN IGG is DFH.

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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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