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FDA 510(k)

STRATUS CS TROPONIN I CALIBRATOR

K-Number: K012233 · 2001-09-11

ApplicantDade Behring, Inc.
Decision Date2001-09-11
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STRATUS CS TROPONIN I CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2001-09-11 under 510(k) number K012233. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS CS TROPONIN I CALIBRATOR?

STRATUS CS TROPONIN I CALIBRATOR is a medical device that received FDA 510(k) clearance on 2001-09-11. The listed applicant is Dade Behring, Inc.. The 510(k) number is K012233.

When did STRATUS CS TROPONIN I CALIBRATOR receive FDA 510(k) clearance?

STRATUS CS TROPONIN I CALIBRATOR received FDA 510(k) clearance on 2001-09-11, under 510(k) number K012233.

Who is the listed applicant for STRATUS CS TROPONIN I CALIBRATOR?

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

What is the FDA product code for STRATUS CS TROPONIN I CALIBRATOR?

The FDA product code for STRATUS CS TROPONIN I CALIBRATOR is JIT.

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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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