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FDA 510(k)

CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27

K-Number: K062152 · 2006-08-16

ApplicantDade Behring, Inc.
Decision Date2006-08-16
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 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 2006-08-16 under 510(k) number K062152. 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 CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27?

CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 is a medical device that received FDA 510(k) clearance on 2006-08-16. The listed applicant is Dade Behring, Inc.. The 510(k) number is K062152.

When did CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 receive FDA 510(k) clearance?

CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 received FDA 510(k) clearance on 2006-08-16, under 510(k) number K062152.

Who is the listed applicant for CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27?

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 CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27?

The FDA product code for CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 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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