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FDA 510(k)

ASO-CUBE(TM)

K-Number: K901371 · 1990-05-15

ApplicantDifco Laboratories, Inc.
Decision Date1990-05-15
Product CodeGTQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ASO-CUBE(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Difco Laboratories, Inc.. It received FDA 510(k) clearance on 1990-05-15 under 510(k) number K901371. The device is classified under product code GTQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASO-CUBE(TM)?

ASO-CUBE(TM) is a medical device that received FDA 510(k) clearance on 1990-05-15. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K901371.

When did ASO-CUBE(TM) receive FDA 510(k) clearance?

ASO-CUBE(TM) received FDA 510(k) clearance on 1990-05-15, under 510(k) number K901371.

Who is the listed applicant for ASO-CUBE(TM)?

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

What is the FDA product code for ASO-CUBE(TM)?

The FDA product code for ASO-CUBE(TM) is GTQ.

Other records listing Difco Laboratories, Inc. as applicant

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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Related Devices (Code: GTQ)

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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