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FDA 510(k)

BERICHROM ANTITHROMBIN III (A)

K-Number: K933125 · 1994-04-19

ApplicantBehring Diagnostics, Inc.
Decision Date1994-04-19
Product CodeJPE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BERICHROM ANTITHROMBIN III (A) 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 1994-04-19 under 510(k) number K933125. The device is classified under product code JPE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BERICHROM ANTITHROMBIN III (A)?

BERICHROM ANTITHROMBIN III (A) is a medical device that received FDA 510(k) clearance on 1994-04-19. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K933125.

When did BERICHROM ANTITHROMBIN III (A) receive FDA 510(k) clearance?

BERICHROM ANTITHROMBIN III (A) received FDA 510(k) clearance on 1994-04-19, under 510(k) number K933125.

Who is the listed applicant for BERICHROM ANTITHROMBIN III (A)?

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 BERICHROM ANTITHROMBIN III (A)?

The FDA product code for BERICHROM ANTITHROMBIN III (A) is JPE.

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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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