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FDA 510(k)

IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G

K-Number: K013432 · 2001-11-29

ApplicantImmuno Concepts, Inc.
Decision Date2001-11-29
Product CodeKTL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G 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 2001-11-29 under 510(k) number K013432. 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 IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G?

IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G is a medical device that received FDA 510(k) clearance on 2001-11-29. The listed applicant is Immuno Concepts, Inc.. The 510(k) number is K013432.

When did IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G receive FDA 510(k) clearance?

IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G received FDA 510(k) clearance on 2001-11-29, under 510(k) number K013432.

Who is the listed applicant for IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G?

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 IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G?

The FDA product code for IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G is KTL.

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Related Devices (Code: KTL)

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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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