FDA 510(k)

CYTOMEGALOVIRUS ANTOBODY IGG

K-Number: K822606 · 1982-11-01

Decision Date1982-11-01

Product CodeLIN

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

CYTOMEGALOVIRUS ANTOBODY IGG is the device name listed in this FDA 510(k) record. The listed applicant is Immulok, Inc.. It received FDA 510(k) clearance on 1982-11-01 under 510(k) number K822606. The device is classified under product code LIN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOMEGALOVIRUS ANTOBODY IGG?

CYTOMEGALOVIRUS ANTOBODY IGG is a medical device that received FDA 510(k) clearance on 1982-11-01. The listed applicant is Immulok, Inc.. The 510(k) number is K822606.

When did CYTOMEGALOVIRUS ANTOBODY IGG receive FDA 510(k) clearance?

CYTOMEGALOVIRUS ANTOBODY IGG received FDA 510(k) clearance on 1982-11-01, under 510(k) number K822606.

Who is the listed applicant for CYTOMEGALOVIRUS ANTOBODY IGG?

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

What is the FDA product code for CYTOMEGALOVIRUS ANTOBODY IGG?

The FDA product code for CYTOMEGALOVIRUS ANTOBODY IGG is LIN.

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Related Devices (Code: LIN)

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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.