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FDA 510(k)

ANA-DISC SYSTEM

K-Number: K820308 · 1982-03-04

ApplicantFlow Laboratories, Inc.
Decision Date1982-03-04
Product CodeKZJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ANA-DISC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Flow Laboratories, Inc.. It received FDA 510(k) clearance on 1982-03-04 under 510(k) number K820308. The device is classified under product code KZJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANA-DISC SYSTEM?

ANA-DISC SYSTEM is a medical device that received FDA 510(k) clearance on 1982-03-04. The listed applicant is Flow Laboratories, Inc.. The 510(k) number is K820308.

When did ANA-DISC SYSTEM receive FDA 510(k) clearance?

ANA-DISC SYSTEM received FDA 510(k) clearance on 1982-03-04, under 510(k) number K820308.

Who is the listed applicant for ANA-DISC SYSTEM?

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

What is the FDA product code for ANA-DISC SYSTEM?

The FDA product code for ANA-DISC SYSTEM is KZJ.

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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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