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FDA 510(k)

FITC ANTISERA TO HUMAN IGM

K-Number: K822677 · 1982-11-17

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

Device Summary

FITC ANTISERA TO HUMAN IGM 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 K822677. 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 FITC ANTISERA TO HUMAN IGM?

FITC ANTISERA TO HUMAN IGM 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 K822677.

When did FITC ANTISERA TO HUMAN IGM receive FDA 510(k) clearance?

FITC ANTISERA TO HUMAN IGM received FDA 510(k) clearance on 1982-11-17, under 510(k) number K822677.

Who is the listed applicant for FITC ANTISERA TO HUMAN IGM?

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 FITC ANTISERA TO HUMAN IGM?

The FDA product code for FITC ANTISERA TO HUMAN IGM 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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