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FDA 510(k)

CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST

K-Number: K810301 · 1981-02-25

ApplicantImmuno Concepts, Inc.
Decision Date1981-02-25
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Immuno Concepts, Inc.. It received FDA 510(k) clearance on 1981-02-25 under 510(k) number K810301. 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 CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST?

CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST is a medical device that received FDA 510(k) clearance on 1981-02-25. The listed applicant is Immuno Concepts, Inc.. The 510(k) number is K810301.

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

CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST received FDA 510(k) clearance on 1981-02-25, under 510(k) number K810301.

Who is the listed applicant for CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST?

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

What is the FDA product code for CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST?

The FDA product code for CRITHIDIA LUCILIAE NATIVE DNA-IFA TEST is DHN.

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Related Devices (Code: DHN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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