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FDA 510(k)

DAPTOMYCIN

K-Number: K042392 · 2004-12-13

ApplicantAb Biodisk
Decision Date2004-12-13
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DAPTOMYCIN is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk. It received FDA 510(k) clearance on 2004-12-13 under 510(k) number K042392. 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 DAPTOMYCIN?

DAPTOMYCIN is a medical device that received FDA 510(k) clearance on 2004-12-13. The listed applicant is Ab Biodisk. The 510(k) number is K042392.

When did DAPTOMYCIN receive FDA 510(k) clearance?

DAPTOMYCIN received FDA 510(k) clearance on 2004-12-13, under 510(k) number K042392.

Who is the listed applicant for DAPTOMYCIN?

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 DAPTOMYCIN?

The FDA product code for DAPTOMYCIN 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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