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FDA 510(k)

N LATEX CRP MONO REAGENT

K-Number: K964687 · 1996-12-16

ApplicantBehring Diagnostics, Inc.
Decision Date1996-12-16
Product CodeDCH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N LATEX CRP MONO 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 1996-12-16 under 510(k) number K964687. The device is classified under product code DCH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N LATEX CRP MONO REAGENT?

N LATEX CRP MONO REAGENT is a medical device that received FDA 510(k) clearance on 1996-12-16. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K964687.

When did N LATEX CRP MONO REAGENT receive FDA 510(k) clearance?

N LATEX CRP MONO REAGENT received FDA 510(k) clearance on 1996-12-16, under 510(k) number K964687.

Who is the listed applicant for N LATEX CRP MONO 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 N LATEX CRP MONO REAGENT?

The FDA product code for N LATEX CRP MONO REAGENT is DCH.

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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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