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FDA 510(k)

PATHROMTIN SL

K-Number: K955450 · 1996-04-19

ApplicantBehring Diagnostics, Inc.
Decision Date1996-04-19
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PATHROMTIN SL 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 1996-04-19 under 510(k) number K955450. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHROMTIN SL?

PATHROMTIN SL is a medical device that received FDA 510(k) clearance on 1996-04-19. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K955450.

When did PATHROMTIN SL receive FDA 510(k) clearance?

PATHROMTIN SL received FDA 510(k) clearance on 1996-04-19, under 510(k) number K955450.

Who is the listed applicant for PATHROMTIN SL?

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 PATHROMTIN SL?

The FDA product code for PATHROMTIN SL is GFO.

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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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