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FDA 510(k)

REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM

K-Number: K922646 · 1993-06-25

ApplicantBehring Diagnostics, Inc.
Decision Date1993-06-25
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM 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 1993-06-25 under 510(k) number K922646. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM?

REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM is a medical device that received FDA 510(k) clearance on 1993-06-25. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K922646.

When did REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM receive FDA 510(k) clearance?

REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM received FDA 510(k) clearance on 1993-06-25, under 510(k) number K922646.

Who is the listed applicant for REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM?

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 REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM?

The FDA product code for REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM is JIS.

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Other records listing Behring Diagnostics, Inc. as applicant

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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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