FDA 510(k)

PS II

K-Number: K943513 · 1995-05-11

Decision Date1995-05-11

Product CodeLYR

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

PS II is the device name listed in this FDA 510(k) record. The listed applicant is Washington Biotechnology. It received FDA 510(k) clearance on 1995-05-11 under 510(k) number K943513. The device is classified under product code LYR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PS II?

PS II is a medical device that received FDA 510(k) clearance on 1995-05-11. The listed applicant is Washington Biotechnology. The 510(k) number is K943513.

When did PS II receive FDA 510(k) clearance?

PS II received FDA 510(k) clearance on 1995-05-11, under 510(k) number K943513.

Who is the listed applicant for PS II?

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

What is the FDA product code for PS II?

The FDA product code for PS II is LYR.

Related Devices (Code: LYR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232892Hp Detect™ Stool Antigen ELISABiomerica, Inc.K230901Premier HpSA Flex (619096)Meridian Bioscience, Inc.K192817Curian HpSA, Curian AnalyzerMeridian Bioscience, Inc.K183573Vstrip H. pylori Antigen Rapid TestPanion & BF Biotech, Inc.K182559PREMIER Platinum HpSA PLUSMeridian Bioscience, Inc.K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetDiaSorin, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.