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FDA 510(k)

EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT

K-Number: K060385 · 2006-04-06

ApplicantDade Behring, Inc.
Decision Date2006-04-06
Product CodeMLM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT 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 2006-04-06 under 510(k) number K060385. The device is classified under product code MLM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT?

EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT is a medical device that received FDA 510(k) clearance on 2006-04-06. The listed applicant is Dade Behring, Inc.. The 510(k) number is K060385.

When did EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT receive FDA 510(k) clearance?

EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT received FDA 510(k) clearance on 2006-04-06, under 510(k) number K060385.

Who is the listed applicant for EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT?

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 EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT?

The FDA product code for EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT is MLM.

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Related Devices (Code: MLM)

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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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