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FDA 510(k)

TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM

K-Number: K973616 · 1997-12-05

ApplicantBayer Corp.
Decision Date1997-12-05
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Corp.. It received FDA 510(k) clearance on 1997-12-05 under 510(k) number K973616. 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 TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM?

TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM is a medical device that received FDA 510(k) clearance on 1997-12-05. The listed applicant is Bayer Corp.. The 510(k) number is K973616.

When did TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM receive FDA 510(k) clearance?

TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM received FDA 510(k) clearance on 1997-12-05, under 510(k) number K973616.

Who is the listed applicant for TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM?

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

What is the FDA product code for TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM?

The FDA product code for TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM is MMI.

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Related Devices (Code: 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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