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FDA 510(k)

GOULD XCALIBER

K-Number: K862344 · 1986-08-06

ApplicantBio-Tek Instruments, Inc.
Decision Date1986-08-06
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GOULD XCALIBER is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Tek Instruments, Inc.. It received FDA 510(k) clearance on 1986-08-06 under 510(k) number K862344. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOULD XCALIBER?

GOULD XCALIBER is a medical device that received FDA 510(k) clearance on 1986-08-06. The listed applicant is Bio-Tek Instruments, Inc.. The 510(k) number is K862344.

When did GOULD XCALIBER receive FDA 510(k) clearance?

GOULD XCALIBER received FDA 510(k) clearance on 1986-08-06, under 510(k) number K862344.

Who is the listed applicant for GOULD XCALIBER?

The FDA 510(k) record lists Bio-Tek Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GOULD XCALIBER?

The FDA product code for GOULD XCALIBER is DRS.

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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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