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FDA 510(k)

N/T RHEUMATOLOGY CONTROL SL/1, SL/2

K-Number: K944375 · 1994-10-03

ApplicantBehring Diagnostics, Inc.
Decision Date1994-10-03
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

N/T RHEUMATOLOGY CONTROL SL/1, SL/2 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 1994-10-03 under 510(k) number K944375. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N/T RHEUMATOLOGY CONTROL SL/1, SL/2?

N/T RHEUMATOLOGY CONTROL SL/1, SL/2 is a medical device that received FDA 510(k) clearance on 1994-10-03. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K944375.

When did N/T RHEUMATOLOGY CONTROL SL/1, SL/2 receive FDA 510(k) clearance?

N/T RHEUMATOLOGY CONTROL SL/1, SL/2 received FDA 510(k) clearance on 1994-10-03, under 510(k) number K944375.

Who is the listed applicant for N/T RHEUMATOLOGY CONTROL SL/1, SL/2?

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/T RHEUMATOLOGY CONTROL SL/1, SL/2?

The FDA product code for N/T RHEUMATOLOGY CONTROL SL/1, SL/2 is DCK.

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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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