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FDA 510(k)

BEHRING COAGULATION SYSTEM (BCS)

K-Number: K992959 · 2000-01-11

ApplicantDade Behring, Inc.
Decision Date2000-01-11
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BEHRING COAGULATION SYSTEM (BCS) 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 2000-01-11 under 510(k) number K992959. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEHRING COAGULATION SYSTEM (BCS)?

BEHRING COAGULATION SYSTEM (BCS) is a medical device that received FDA 510(k) clearance on 2000-01-11. The listed applicant is Dade Behring, Inc.. The 510(k) number is K992959.

When did BEHRING COAGULATION SYSTEM (BCS) receive FDA 510(k) clearance?

BEHRING COAGULATION SYSTEM (BCS) received FDA 510(k) clearance on 2000-01-11, under 510(k) number K992959.

Who is the listed applicant for BEHRING COAGULATION SYSTEM (BCS)?

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 BEHRING COAGULATION SYSTEM (BCS)?

The FDA product code for BEHRING COAGULATION SYSTEM (BCS) is JPA.

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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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