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FDA 510(k)

BATROXOBIN REAGENT

K-Number: K932787 · 1993-11-29

ApplicantBehring Diagnostics, Inc.
Decision Date1993-11-29
Product CodeJCO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BATROXOBIN REAGENT 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 1993-11-29 under 510(k) number K932787. The device is classified under product code JCO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BATROXOBIN REAGENT?

BATROXOBIN REAGENT is a medical device that received FDA 510(k) clearance on 1993-11-29. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K932787.

When did BATROXOBIN REAGENT receive FDA 510(k) clearance?

BATROXOBIN REAGENT received FDA 510(k) clearance on 1993-11-29, under 510(k) number K932787.

Who is the listed applicant for BATROXOBIN REAGENT?

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 BATROXOBIN REAGENT?

The FDA product code for BATROXOBIN REAGENT is JCO.

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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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