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FDA 510(k)

REVISED C-REACTIVE PROTEIN CALIBRATOR

K-Number: K990824 · 1999-04-16

ApplicantDade Behring, Inc.
Decision Date1999-04-16
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REVISED C-REACTIVE PROTEIN CALIBRATOR 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 1999-04-16 under 510(k) number K990824. 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 REVISED C-REACTIVE PROTEIN CALIBRATOR?

REVISED C-REACTIVE PROTEIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 1999-04-16. The listed applicant is Dade Behring, Inc.. The 510(k) number is K990824.

When did REVISED C-REACTIVE PROTEIN CALIBRATOR receive FDA 510(k) clearance?

REVISED C-REACTIVE PROTEIN CALIBRATOR received FDA 510(k) clearance on 1999-04-16, under 510(k) number K990824.

Who is the listed applicant for REVISED C-REACTIVE PROTEIN CALIBRATOR?

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 REVISED C-REACTIVE PROTEIN CALIBRATOR?

The FDA product code for REVISED C-REACTIVE PROTEIN CALIBRATOR is JIT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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