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FDA 510(k)

ANTIGENZ CHLAMYDIA

K-Number: K905402 · 1991-03-11

ApplicantNorthumbria Biologicals , Ltd.
Decision Date1991-03-11
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ANTIGENZ CHLAMYDIA is the device name listed in this FDA 510(k) record. The listed applicant is Northumbria Biologicals , Ltd.. It received FDA 510(k) clearance on 1991-03-11 under 510(k) number K905402. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTIGENZ CHLAMYDIA?

ANTIGENZ CHLAMYDIA is a medical device that received FDA 510(k) clearance on 1991-03-11. The listed applicant is Northumbria Biologicals , Ltd.. The 510(k) number is K905402.

When did ANTIGENZ CHLAMYDIA receive FDA 510(k) clearance?

ANTIGENZ CHLAMYDIA received FDA 510(k) clearance on 1991-03-11, under 510(k) number K905402.

Who is the listed applicant for ANTIGENZ CHLAMYDIA?

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

What is the FDA product code for ANTIGENZ CHLAMYDIA?

The FDA product code for ANTIGENZ CHLAMYDIA is GZB.

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Official Source

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