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FDA 510(k)

DUAL SUBSTRATE ANA

K-Number: K871395 · 1987-04-20

ApplicantVal Tech Diagnostics, Inc.
Decision Date1987-04-20
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DUAL SUBSTRATE ANA is the device name listed in this FDA 510(k) record. The listed applicant is Val Tech Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-04-20 under 510(k) number K871395. 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 DUAL SUBSTRATE ANA?

DUAL SUBSTRATE ANA is a medical device that received FDA 510(k) clearance on 1987-04-20. The listed applicant is Val Tech Diagnostics, Inc.. The 510(k) number is K871395.

When did DUAL SUBSTRATE ANA receive FDA 510(k) clearance?

DUAL SUBSTRATE ANA received FDA 510(k) clearance on 1987-04-20, under 510(k) number K871395.

Who is the listed applicant for DUAL SUBSTRATE ANA?

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

What is the FDA product code for DUAL SUBSTRATE ANA?

The FDA product code for DUAL SUBSTRATE ANA is DHN.

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Other records listing Val Tech Diagnostics, Inc. as applicant

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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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