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FDA 510(k)

BEHRING NEPHELOMETER II

K-Number: K943997 · 1994-10-03

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

Device Summary

BEHRING NEPHELOMETER II 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 K943997. The device is classified under product code DEW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEHRING NEPHELOMETER II?

BEHRING NEPHELOMETER II 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 K943997.

When did BEHRING NEPHELOMETER II receive FDA 510(k) clearance?

BEHRING NEPHELOMETER II received FDA 510(k) clearance on 1994-10-03, under 510(k) number K943997.

Who is the listed applicant for BEHRING NEPHELOMETER II?

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 BEHRING NEPHELOMETER II?

The FDA product code for BEHRING NEPHELOMETER II is DEW.

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Other records listing Behring Diagnostics, Inc. as applicant

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Related Devices (Code: DEW)

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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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