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FDA 510(k)

N RHEUMATOLOGY STANDARD SL

K-Number: K964527 · 1997-01-15

ApplicantBehring Diagnostics, Inc.
Decision Date1997-01-15
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

N RHEUMATOLOGY STANDARD 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 1997-01-15 under 510(k) number K964527. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the N RHEUMATOLOGY STANDARD SL?

N RHEUMATOLOGY STANDARD SL is a medical device that received FDA 510(k) clearance on 1997-01-15. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K964527.

When did N RHEUMATOLOGY STANDARD SL receive FDA 510(k) clearance?

N RHEUMATOLOGY STANDARD SL received FDA 510(k) clearance on 1997-01-15, under 510(k) number K964527.

Who is the listed applicant for N RHEUMATOLOGY STANDARD 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 N RHEUMATOLOGY STANDARD SL?

The FDA product code for N RHEUMATOLOGY STANDARD SL is JIX.

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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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