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FDA 510(k)

AIA-PACK TROPONIN I ASSAY

K-Number: K984359 · 1998-12-23

ApplicantTosoh Medics, Inc.
Decision Date1998-12-23
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AIA-PACK TROPONIN I ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Medics, Inc.. It received FDA 510(k) clearance on 1998-12-23 under 510(k) number K984359. 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 AIA-PACK TROPONIN I ASSAY?

AIA-PACK TROPONIN I ASSAY is a medical device that received FDA 510(k) clearance on 1998-12-23. The listed applicant is Tosoh Medics, Inc.. The 510(k) number is K984359.

When did AIA-PACK TROPONIN I ASSAY receive FDA 510(k) clearance?

AIA-PACK TROPONIN I ASSAY received FDA 510(k) clearance on 1998-12-23, under 510(k) number K984359.

Who is the listed applicant for AIA-PACK TROPONIN I ASSAY?

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

What is the FDA product code for AIA-PACK TROPONIN I ASSAY?

The FDA product code for AIA-PACK TROPONIN I ASSAY 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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