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FDA 510(k)

NEOTHROMITIN(R)

K-Number: K924395 · 1992-12-01

ApplicantBehring Diagnostics, Inc.
Decision Date1992-12-01
Product CodeGPO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NEOTHROMITIN(R) 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 1992-12-01 under 510(k) number K924395. The device is classified under product code GPO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEOTHROMITIN(R)?

NEOTHROMITIN(R) is a medical device that received FDA 510(k) clearance on 1992-12-01. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K924395.

When did NEOTHROMITIN(R) receive FDA 510(k) clearance?

NEOTHROMITIN(R) received FDA 510(k) clearance on 1992-12-01, under 510(k) number K924395.

Who is the listed applicant for NEOTHROMITIN(R)?

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 NEOTHROMITIN(R)?

The FDA product code for NEOTHROMITIN(R) is GPO.

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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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