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FDA 510(k)

THE EMIT 2000 TACROLIMUS CALIBRATORS

K-Number: K060371 · 2006-03-09

ApplicantDade Behring, Inc.
Decision Date2006-03-09
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

THE EMIT 2000 TACROLIMUS CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2006-03-09 under 510(k) number K060371. 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 THE EMIT 2000 TACROLIMUS CALIBRATORS?

THE EMIT 2000 TACROLIMUS CALIBRATORS is a medical device that received FDA 510(k) clearance on 2006-03-09. The listed applicant is Dade Behring, Inc.. The 510(k) number is K060371.

When did THE EMIT 2000 TACROLIMUS CALIBRATORS receive FDA 510(k) clearance?

THE EMIT 2000 TACROLIMUS CALIBRATORS received FDA 510(k) clearance on 2006-03-09, under 510(k) number K060371.

Who is the listed applicant for THE EMIT 2000 TACROLIMUS CALIBRATORS?

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

What is the FDA product code for THE EMIT 2000 TACROLIMUS CALIBRATORS?

The FDA product code for THE EMIT 2000 TACROLIMUS CALIBRATORS is JIT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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