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FDA 510(k)

SYSTEM U3 FOR CEPHALOTHIN

K-Number: K984581 · 1999-03-09

ApplicantAb Biodisk
Decision Date1999-03-09
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SYSTEM U3 FOR CEPHALOTHIN is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk. It received FDA 510(k) clearance on 1999-03-09 under 510(k) number K984581. 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 SYSTEM U3 FOR CEPHALOTHIN?

SYSTEM U3 FOR CEPHALOTHIN is a medical device that received FDA 510(k) clearance on 1999-03-09. The listed applicant is Ab Biodisk. The 510(k) number is K984581.

When did SYSTEM U3 FOR CEPHALOTHIN receive FDA 510(k) clearance?

SYSTEM U3 FOR CEPHALOTHIN received FDA 510(k) clearance on 1999-03-09, under 510(k) number K984581.

Who is the listed applicant for SYSTEM U3 FOR CEPHALOTHIN?

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 SYSTEM U3 FOR CEPHALOTHIN?

The FDA product code for SYSTEM U3 FOR CEPHALOTHIN is JWY.

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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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