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FDA 510(k)

ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)

K-Number: K884400 · 1988-11-04

ApplicantImmco Diagnostics, Inc.
Decision Date1988-11-04
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE) is the device name listed in this FDA 510(k) record. The listed applicant is Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 1988-11-04 under 510(k) number K884400. 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 DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)?

ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE) is a medical device that received FDA 510(k) clearance on 1988-11-04. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K884400.

When did ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE) receive FDA 510(k) clearance?

ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE) received FDA 510(k) clearance on 1988-11-04, under 510(k) number K884400.

Who is the listed applicant for ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)?

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

What is the FDA product code for ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)?

The FDA product code for ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE) 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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