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FDA 510(k)

ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES

K-Number: K982429 · 1998-08-25

ApplicantZymetx, Inc.
Decision Date1998-08-25
Product CodePSZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES is the device name listed in this FDA 510(k) record. The listed applicant is Zymetx, Inc.. It received FDA 510(k) clearance on 1998-08-25 under 510(k) number K982429. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES?

ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES is a medical device that received FDA 510(k) clearance on 1998-08-25. The listed applicant is Zymetx, Inc.. The 510(k) number is K982429.

When did ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES receive FDA 510(k) clearance?

ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES received FDA 510(k) clearance on 1998-08-25, under 510(k) number K982429.

Who is the listed applicant for ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES?

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

What is the FDA product code for ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES?

The FDA product code for ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES is PSZ.

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Other records listing Zymetx, Inc. as applicant

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.

K984596VIRASTAT FITC-LABELED ANTI-INFLUENZA A AND B MONOCLONAL ANTIBODIESK971494VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSESK950838VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES

Related Devices (Code: PSZ)

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.

K254262Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIAOrtho Clinical Diagnostics Inc. (QuidelOrtho)K252283Nano-Check Influenza A+B TestNano-Ditech CorporationK250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemSEKISUI Diagnostics, LLCK232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBdK223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd

Official Source

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