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FDA 510(k)

CALIBRATING MATERIAL, CALIBRATING STANDARDS

K-Number: K033060 · 2004-03-04

ApplicantDiamond Diagnostics, Inc.
Decision Date2004-03-04
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CALIBRATING MATERIAL, CALIBRATING STANDARDS 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 2004-03-04 under 510(k) number K033060. 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 CALIBRATING MATERIAL, CALIBRATING STANDARDS?

CALIBRATING MATERIAL, CALIBRATING STANDARDS is a medical device that received FDA 510(k) clearance on 2004-03-04. The listed applicant is Diamond Diagnostics, Inc.. The 510(k) number is K033060.

When did CALIBRATING MATERIAL, CALIBRATING STANDARDS receive FDA 510(k) clearance?

CALIBRATING MATERIAL, CALIBRATING STANDARDS received FDA 510(k) clearance on 2004-03-04, under 510(k) number K033060.

Who is the listed applicant for CALIBRATING MATERIAL, CALIBRATING STANDARDS?

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 CALIBRATING MATERIAL, CALIBRATING STANDARDS?

The FDA product code for CALIBRATING MATERIAL, CALIBRATING STANDARDS is JIT.

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Related Devices (Code: 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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