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FDA 510(k)

NORMAL AND HYPERGAMMA CONTROL SERUM

K-Number: K040925 · 2004-04-28

ApplicantSebia
Decision Date2004-04-28
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NORMAL AND HYPERGAMMA CONTROL SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Sebia. It received FDA 510(k) clearance on 2004-04-28 under 510(k) number K040925. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORMAL AND HYPERGAMMA CONTROL SERUM?

NORMAL AND HYPERGAMMA CONTROL SERUM is a medical device that received FDA 510(k) clearance on 2004-04-28. The listed applicant is Sebia. The 510(k) number is K040925.

When did NORMAL AND HYPERGAMMA CONTROL SERUM receive FDA 510(k) clearance?

NORMAL AND HYPERGAMMA CONTROL SERUM received FDA 510(k) clearance on 2004-04-28, under 510(k) number K040925.

Who is the listed applicant for NORMAL AND HYPERGAMMA CONTROL SERUM?

The FDA 510(k) record lists Sebia as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORMAL AND HYPERGAMMA CONTROL SERUM?

The FDA product code for NORMAL AND HYPERGAMMA CONTROL SERUM is JJY.

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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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