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FDA 510(k)

VIDAS TROPONIN I (TNI), MODEL 30 445

K-Number: K030950 · 2003-06-16

ApplicantbioMerieux, Inc.
Decision Date2003-06-16
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VIDAS TROPONIN I (TNI), MODEL 30 445 is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2003-06-16 under 510(k) number K030950. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDAS TROPONIN I (TNI), MODEL 30 445?

VIDAS TROPONIN I (TNI), MODEL 30 445 is a medical device that received FDA 510(k) clearance on 2003-06-16. The listed applicant is bioMerieux, Inc.. The 510(k) number is K030950.

When did VIDAS TROPONIN I (TNI), MODEL 30 445 receive FDA 510(k) clearance?

VIDAS TROPONIN I (TNI), MODEL 30 445 received FDA 510(k) clearance on 2003-06-16, under 510(k) number K030950.

Who is the listed applicant for VIDAS TROPONIN I (TNI), MODEL 30 445?

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

What is the FDA product code for VIDAS TROPONIN I (TNI), MODEL 30 445?

The FDA product code for VIDAS TROPONIN I (TNI), MODEL 30 445 is MMI.

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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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