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FDA 510(k)

ARCHITECT TACROLIMUS: MODEL 1L77

K-Number: K070820 · 2007-08-01

ApplicantFujirebio Diagnostics,Inc.
Decision Date2007-08-01
Product CodeMLM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARCHITECT TACROLIMUS: MODEL 1L77 is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2007-08-01 under 510(k) number K070820. 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 ARCHITECT TACROLIMUS: MODEL 1L77?

ARCHITECT TACROLIMUS: MODEL 1L77 is a medical device that received FDA 510(k) clearance on 2007-08-01. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K070820.

When did ARCHITECT TACROLIMUS: MODEL 1L77 receive FDA 510(k) clearance?

ARCHITECT TACROLIMUS: MODEL 1L77 received FDA 510(k) clearance on 2007-08-01, under 510(k) number K070820.

Who is the listed applicant for ARCHITECT TACROLIMUS: MODEL 1L77?

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

What is the FDA product code for ARCHITECT TACROLIMUS: MODEL 1L77?

The FDA product code for ARCHITECT TACROLIMUS: MODEL 1L77 is 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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