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FDA 510(k)

ALIBI BIOLOGICAL INDICATOR, MODEL WS

K-Number: K024079 · 2003-02-27

ApplicantArden Laboratories, Incorporated
Decision Date2003-02-27
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ALIBI BIOLOGICAL INDICATOR, MODEL WS is the device name listed in this FDA 510(k) record. The listed applicant is Arden Laboratories, Incorporated. It received FDA 510(k) clearance on 2003-02-27 under 510(k) number K024079. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALIBI BIOLOGICAL INDICATOR, MODEL WS?

ALIBI BIOLOGICAL INDICATOR, MODEL WS is a medical device that received FDA 510(k) clearance on 2003-02-27. The listed applicant is Arden Laboratories, Incorporated. The 510(k) number is K024079.

When did ALIBI BIOLOGICAL INDICATOR, MODEL WS receive FDA 510(k) clearance?

ALIBI BIOLOGICAL INDICATOR, MODEL WS received FDA 510(k) clearance on 2003-02-27, under 510(k) number K024079.

Who is the listed applicant for ALIBI BIOLOGICAL INDICATOR, MODEL WS?

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

What is the FDA product code for ALIBI BIOLOGICAL INDICATOR, MODEL WS?

The FDA product code for ALIBI BIOLOGICAL INDICATOR, MODEL WS is FRC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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