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FDA 510(k)

BECKMAN COULTER DNASE B CALIBRATOR

K-Number: K010696 · 2001-05-10

ApplicantBeckman Coulter, Inc.
Decision Date2001-05-10
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BECKMAN COULTER DNASE B CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2001-05-10 under 510(k) number K010696. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BECKMAN COULTER DNASE B CALIBRATOR?

BECKMAN COULTER DNASE B CALIBRATOR is a medical device that received FDA 510(k) clearance on 2001-05-10. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K010696.

When did BECKMAN COULTER DNASE B CALIBRATOR receive FDA 510(k) clearance?

BECKMAN COULTER DNASE B CALIBRATOR received FDA 510(k) clearance on 2001-05-10, under 510(k) number K010696.

Who is the listed applicant for BECKMAN COULTER DNASE B CALIBRATOR?

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

What is the FDA product code for BECKMAN COULTER DNASE B CALIBRATOR?

The FDA product code for BECKMAN COULTER DNASE B CALIBRATOR is JIS.

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Related Devices (Code: JIS)

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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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