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FDA 510(k)

FERRITIN CALIBRATOR

K-Number: K963493 · 1996-12-03

ApplicantDade Chemistry Systems, Inc.
Decision Date1996-12-03
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FERRITIN CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Dade Chemistry Systems, Inc.. It received FDA 510(k) clearance on 1996-12-03 under 510(k) number K963493. 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 FERRITIN CALIBRATOR?

FERRITIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 1996-12-03. The listed applicant is Dade Chemistry Systems, Inc.. The 510(k) number is K963493.

When did FERRITIN CALIBRATOR receive FDA 510(k) clearance?

FERRITIN CALIBRATOR received FDA 510(k) clearance on 1996-12-03, under 510(k) number K963493.

Who is the listed applicant for FERRITIN CALIBRATOR?

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

What is the FDA product code for FERRITIN CALIBRATOR?

The FDA product code for FERRITIN CALIBRATOR is JIT.

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Other records listing Dade Chemistry Systems, Inc. as applicant

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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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