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FDA 510(k)

BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY

K-Number: K952478 · 1995-11-09

ApplicantBoehringer Mannheim Corp.
Decision Date1995-11-09
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1995-11-09 under 510(k) number K952478. 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 BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY?

BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY is a medical device that received FDA 510(k) clearance on 1995-11-09. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K952478.

When did BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY receive FDA 510(k) clearance?

BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY received FDA 510(k) clearance on 1995-11-09, under 510(k) number K952478.

Who is the listed applicant for BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY?

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

What is the FDA product code for BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY?

The FDA product code for BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID 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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