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FDA 510(k)

ACCESS ULTRASENSITIVE HGH CALIBRATORS

K-Number: K003098 · 2000-11-20

ApplicantBeckman Coulter, Inc.
Decision Date2000-11-20
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCESS ULTRASENSITIVE HGH CALIBRATORS 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 2000-11-20 under 510(k) number K003098. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESS ULTRASENSITIVE HGH CALIBRATORS?

ACCESS ULTRASENSITIVE HGH CALIBRATORS is a medical device that received FDA 510(k) clearance on 2000-11-20. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K003098.

When did ACCESS ULTRASENSITIVE HGH CALIBRATORS receive FDA 510(k) clearance?

ACCESS ULTRASENSITIVE HGH CALIBRATORS received FDA 510(k) clearance on 2000-11-20, under 510(k) number K003098.

Who is the listed applicant for ACCESS ULTRASENSITIVE HGH CALIBRATORS?

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 ACCESS ULTRASENSITIVE HGH CALIBRATORS?

The FDA product code for ACCESS ULTRASENSITIVE HGH CALIBRATORS is JIT.

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Related Devices (Code: JIT)

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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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