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FDA 510(k)

BEHRING COAGULATION SYSTEM

K-Number: K970431 · 1997-05-05

ApplicantBehring Diagnostics, Inc.
Decision Date1997-05-05
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BEHRING COAGULATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-05-05 under 510(k) number K970431. 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?

BEHRING COAGULATION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-05-05. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K970431.

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

BEHRING COAGULATION SYSTEM received FDA 510(k) clearance on 1997-05-05, under 510(k) number K970431.

Who is the listed applicant for BEHRING COAGULATION SYSTEM?

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

What is the FDA product code for BEHRING COAGULATION SYSTEM?

The FDA product code for BEHRING COAGULATION SYSTEM 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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