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FDA 510(k)

TANGENT SYSTEM(TM) ANA PROFILE TEST KIT

K-Number: K871144 · 1987-04-29

ApplicantVitrotec Laboratories, Inc.
Decision Date1987-04-29
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TANGENT SYSTEM(TM) ANA PROFILE TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Vitrotec Laboratories, Inc.. It received FDA 510(k) clearance on 1987-04-29 under 510(k) number K871144. 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 TANGENT SYSTEM(TM) ANA PROFILE TEST KIT?

TANGENT SYSTEM(TM) ANA PROFILE TEST KIT is a medical device that received FDA 510(k) clearance on 1987-04-29. The listed applicant is Vitrotec Laboratories, Inc.. The 510(k) number is K871144.

When did TANGENT SYSTEM(TM) ANA PROFILE TEST KIT receive FDA 510(k) clearance?

TANGENT SYSTEM(TM) ANA PROFILE TEST KIT received FDA 510(k) clearance on 1987-04-29, under 510(k) number K871144.

Who is the listed applicant for TANGENT SYSTEM(TM) ANA PROFILE TEST KIT?

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

What is the FDA product code for TANGENT SYSTEM(TM) ANA PROFILE TEST KIT?

The FDA product code for TANGENT SYSTEM(TM) ANA PROFILE TEST KIT 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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