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FDA 510(k)

BAYSILEX

K-Number: K854106 · 1986-03-17

ApplicantCutter Laboratories, Inc.
Decision Date1986-03-17
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BAYSILEX is the device name listed in this FDA 510(k) record. The listed applicant is Cutter Laboratories, Inc.. It received FDA 510(k) clearance on 1986-03-17 under 510(k) number K854106. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAYSILEX?

BAYSILEX is a medical device that received FDA 510(k) clearance on 1986-03-17. The listed applicant is Cutter Laboratories, Inc.. The 510(k) number is K854106.

When did BAYSILEX receive FDA 510(k) clearance?

BAYSILEX received FDA 510(k) clearance on 1986-03-17, under 510(k) number K854106.

Who is the listed applicant for BAYSILEX?

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

What is the FDA product code for BAYSILEX?

The FDA product code for BAYSILEX is ELW.

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Related Devices (Code: ELW)

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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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