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FDA 510(k)

ACCESS UNCONJUGATED ESTRIOL CALIBRATORS

K-Number: K012900 · 2001-10-16

ApplicantBeckman Coulter, Inc.
Decision Date2001-10-16
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCESS UNCONJUGATED ESTRIOL 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 2001-10-16 under 510(k) number K012900. 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 UNCONJUGATED ESTRIOL CALIBRATORS?

ACCESS UNCONJUGATED ESTRIOL CALIBRATORS is a medical device that received FDA 510(k) clearance on 2001-10-16. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K012900.

When did ACCESS UNCONJUGATED ESTRIOL CALIBRATORS receive FDA 510(k) clearance?

ACCESS UNCONJUGATED ESTRIOL CALIBRATORS received FDA 510(k) clearance on 2001-10-16, under 510(k) number K012900.

Who is the listed applicant for ACCESS UNCONJUGATED ESTRIOL 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 UNCONJUGATED ESTRIOL CALIBRATORS?

The FDA product code for ACCESS UNCONJUGATED ESTRIOL 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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