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FDA 510(k)

THE E TEST, MODIFICATION

K-Number: K913459 · 1991-09-25

ApplicantAb Biodisk
Decision Date1991-09-25
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

THE E TEST, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk. It received FDA 510(k) clearance on 1991-09-25 under 510(k) number K913459. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE E TEST, MODIFICATION?

THE E TEST, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-09-25. The listed applicant is Ab Biodisk. The 510(k) number is K913459.

When did THE E TEST, MODIFICATION receive FDA 510(k) clearance?

THE E TEST, MODIFICATION received FDA 510(k) clearance on 1991-09-25, under 510(k) number K913459.

Who is the listed applicant for THE E TEST, MODIFICATION?

The FDA 510(k) record lists Ab Biodisk as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE E TEST, MODIFICATION?

The FDA product code for THE E TEST, MODIFICATION is JWY.

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Other records listing Ab Biodisk 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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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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