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FDA 510(k)

ANTI-NATIVE DNA ANTIBODY

K-Number: K834349 · 1984-04-19

ApplicantSigma Chemical Co.
Decision Date1984-04-19
Product CodeKTL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-NATIVE DNA ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1984-04-19 under 510(k) number K834349. The device is classified under product code KTL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-NATIVE DNA ANTIBODY?

ANTI-NATIVE DNA ANTIBODY is a medical device that received FDA 510(k) clearance on 1984-04-19. The listed applicant is Sigma Chemical Co.. The 510(k) number is K834349.

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

ANTI-NATIVE DNA ANTIBODY received FDA 510(k) clearance on 1984-04-19, under 510(k) number K834349.

Who is the listed applicant for ANTI-NATIVE DNA ANTIBODY?

The FDA 510(k) record lists Sigma Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for ANTI-NATIVE DNA ANTIBODY is KTL.

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Other records listing Sigma Chemical Co. as applicant

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Related Devices (Code: KTL)

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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