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FDA 510(k)

ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K

K-Number: K822682 · 1982-12-03

ApplicantAmico Lab, Inc.
Decision Date1982-12-03
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K 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 1982-12-03 under 510(k) number K822682. 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 ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K?

ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K is a medical device that received FDA 510(k) clearance on 1982-12-03. The listed applicant is Amico Lab, Inc.. The 510(k) number is K822682.

When did ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K receive FDA 510(k) clearance?

ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K received FDA 510(k) clearance on 1982-12-03, under 510(k) number K822682.

Who is the listed applicant for ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K?

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 ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K?

The FDA product code for ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K is DHN.

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Related Devices (Code: 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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