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FDA 510(k)

DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH

K-Number: K121027 · 2012-12-20

ApplicantDiamond Diagnostics, Inc.
Decision Date2012-12-20
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH is the device name listed in this FDA 510(k) record. The listed applicant is Diamond Diagnostics, Inc.. It received FDA 510(k) clearance on 2012-12-20 under 510(k) number K121027. 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 DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH?

DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH is a medical device that received FDA 510(k) clearance on 2012-12-20. The listed applicant is Diamond Diagnostics, Inc.. The 510(k) number is K121027.

When did DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH receive FDA 510(k) clearance?

DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH received FDA 510(k) clearance on 2012-12-20, under 510(k) number K121027.

Who is the listed applicant for DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH?

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

What is the FDA product code for DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH?

The FDA product code for DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH 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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