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FDA 510(k)

THROMBOREL S

K-Number: K003870 · 2001-02-20

ApplicantDade Behring, Inc.
Decision Date2001-02-20
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBOREL S 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 2001-02-20 under 510(k) number K003870. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBOREL S?

THROMBOREL S is a medical device that received FDA 510(k) clearance on 2001-02-20. The listed applicant is Dade Behring, Inc.. The 510(k) number is K003870.

When did THROMBOREL S receive FDA 510(k) clearance?

THROMBOREL S received FDA 510(k) clearance on 2001-02-20, under 510(k) number K003870.

Who is the listed applicant for THROMBOREL S?

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 THROMBOREL S?

The FDA product code for THROMBOREL S is GJS.

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Related Devices (Code: GJS)

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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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