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FDA 510(k)

STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C

K-Number: K022977 · 2002-11-27

ApplicantDade Behring, Inc.
Decision Date2002-11-27
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C 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 2002-11-27 under 510(k) number K022977. The device is classified under product code DAP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C?

STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C is a medical device that received FDA 510(k) clearance on 2002-11-27. The listed applicant is Dade Behring, Inc.. The 510(k) number is K022977.

When did STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C receive FDA 510(k) clearance?

STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C received FDA 510(k) clearance on 2002-11-27, under 510(k) number K022977.

Who is the listed applicant for STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C?

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 STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C?

The FDA product code for STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C is DAP.

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Related Devices (Code: DAP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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