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FDA 510(k)

ANTINUCLEAR ANTOBODY CELL SUBSTRATE

K-Number: K822607 · 1982-09-17

ApplicantImmulok, Inc.
Decision Date1982-09-17
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTINUCLEAR ANTOBODY CELL SUBSTRATE is the device name listed in this FDA 510(k) record. The listed applicant is Immulok, Inc.. It received FDA 510(k) clearance on 1982-09-17 under 510(k) number K822607. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTINUCLEAR ANTOBODY CELL SUBSTRATE?

ANTINUCLEAR ANTOBODY CELL SUBSTRATE is a medical device that received FDA 510(k) clearance on 1982-09-17. The listed applicant is Immulok, Inc.. The 510(k) number is K822607.

When did ANTINUCLEAR ANTOBODY CELL SUBSTRATE receive FDA 510(k) clearance?

ANTINUCLEAR ANTOBODY CELL SUBSTRATE received FDA 510(k) clearance on 1982-09-17, under 510(k) number K822607.

Who is the listed applicant for ANTINUCLEAR ANTOBODY CELL SUBSTRATE?

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 ANTINUCLEAR ANTOBODY CELL SUBSTRATE?

The FDA product code for ANTINUCLEAR ANTOBODY CELL SUBSTRATE is DHN.

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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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