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FDA 510(k)

VIGIL DNASE B CONTROL

K-Number: K010693 · 2001-04-11

ApplicantBeckman Coulter, Inc.
Decision Date2001-04-11
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VIGIL DNASE B CONTROL 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 2001-04-11 under 510(k) number K010693. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIGIL DNASE B CONTROL?

VIGIL DNASE B CONTROL is a medical device that received FDA 510(k) clearance on 2001-04-11. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K010693.

When did VIGIL DNASE B CONTROL receive FDA 510(k) clearance?

VIGIL DNASE B CONTROL received FDA 510(k) clearance on 2001-04-11, under 510(k) number K010693.

Who is the listed applicant for VIGIL DNASE B CONTROL?

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 VIGIL DNASE B CONTROL?

The FDA product code for VIGIL DNASE B CONTROL is JJX.

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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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