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FDA 510(k)

FLUORESCENT ANTI-NATIVE DNA TEST

K-Number: K780899 · 1978-09-07

ApplicantKallestad Laboratories, Inc.
Decision Date1978-09-07
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FLUORESCENT ANTI-NATIVE DNA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Kallestad Laboratories, Inc.. It received FDA 510(k) clearance on 1978-09-07 under 510(k) number K780899. 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 FLUORESCENT ANTI-NATIVE DNA TEST?

FLUORESCENT ANTI-NATIVE DNA TEST is a medical device that received FDA 510(k) clearance on 1978-09-07. The listed applicant is Kallestad Laboratories, Inc.. The 510(k) number is K780899.

When did FLUORESCENT ANTI-NATIVE DNA TEST receive FDA 510(k) clearance?

FLUORESCENT ANTI-NATIVE DNA TEST received FDA 510(k) clearance on 1978-09-07, under 510(k) number K780899.

Who is the listed applicant for FLUORESCENT ANTI-NATIVE DNA TEST?

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

What is the FDA product code for FLUORESCENT ANTI-NATIVE DNA TEST?

The FDA product code for FLUORESCENT ANTI-NATIVE DNA TEST 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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