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FDA 510(k)

ENZYME II CALIBRATOR

K-Number: K103836 · 2011-02-16

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2011-02-16
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYME II CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2011-02-16 under 510(k) number K103836. 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 ENZYME II CALIBRATOR?

ENZYME II CALIBRATOR is a medical device that received FDA 510(k) clearance on 2011-02-16. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K103836.

When did ENZYME II CALIBRATOR receive FDA 510(k) clearance?

ENZYME II CALIBRATOR received FDA 510(k) clearance on 2011-02-16, under 510(k) number K103836.

Who is the listed applicant for ENZYME II CALIBRATOR?

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

What is the FDA product code for ENZYME II CALIBRATOR?

The FDA product code for ENZYME II 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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