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FDA 510(k)

HAEMOFUGE A. BIOFUGE A. & B

K-Number: K840767 · 1984-04-17

ApplicantHeraeus-Christ GmbH
Decision Date1984-04-17
Product CodeJPI
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HAEMOFUGE A. BIOFUGE A. & B is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus-Christ GmbH. It received FDA 510(k) clearance on 1984-04-17 under 510(k) number K840767. The device is classified under product code JPI. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAEMOFUGE A. BIOFUGE A. & B?

HAEMOFUGE A. BIOFUGE A. & B is a medical device that received FDA 510(k) clearance on 1984-04-17. The listed applicant is Heraeus-Christ GmbH. The 510(k) number is K840767.

When did HAEMOFUGE A. BIOFUGE A. & B receive FDA 510(k) clearance?

HAEMOFUGE A. BIOFUGE A. & B received FDA 510(k) clearance on 1984-04-17, under 510(k) number K840767.

Who is the listed applicant for HAEMOFUGE A. BIOFUGE A. & B?

The FDA 510(k) record lists Heraeus-Christ GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HAEMOFUGE A. BIOFUGE A. & B?

The FDA product code for HAEMOFUGE A. BIOFUGE A. & B is JPI.

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Other records listing Heraeus-Christ GmbH as applicant

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.

K840768CENTRIFUGES

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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