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FDA 510(k)

AFT-HEP SYSTEM

K-Number: K860183 · 1986-02-26

ApplicantBehring Diagnostics, Inc.
Decision Date1986-02-26
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AFT-HEP 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 1986-02-26 under 510(k) number K860183. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFT-HEP SYSTEM?

AFT-HEP SYSTEM is a medical device that received FDA 510(k) clearance on 1986-02-26. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K860183.

When did AFT-HEP SYSTEM receive FDA 510(k) clearance?

AFT-HEP SYSTEM received FDA 510(k) clearance on 1986-02-26, under 510(k) number K860183.

Who is the listed applicant for AFT-HEP 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 AFT-HEP SYSTEM?

The FDA product code for AFT-HEP SYSTEM is DHN.

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Other records listing Behring Diagnostics, Inc. as applicant

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Related Devices (Code: DHN)

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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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