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FDA 510(k)

BINAXNOX STAPHYLOCOCCUS AUREUS TEST

K-Number: K090964 · 2009-12-16

ApplicantBinax, Inc.
Decision Date2009-12-16
Product CodeJWX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BINAXNOX STAPHYLOCOCCUS AUREUS TEST is the device name listed in this FDA 510(k) record. The listed applicant is Binax, Inc.. It received FDA 510(k) clearance on 2009-12-16 under 510(k) number K090964. The device is classified under product code JWX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BINAXNOX STAPHYLOCOCCUS AUREUS TEST?

BINAXNOX STAPHYLOCOCCUS AUREUS TEST is a medical device that received FDA 510(k) clearance on 2009-12-16. The listed applicant is Binax, Inc.. The 510(k) number is K090964.

When did BINAXNOX STAPHYLOCOCCUS AUREUS TEST receive FDA 510(k) clearance?

BINAXNOX STAPHYLOCOCCUS AUREUS TEST received FDA 510(k) clearance on 2009-12-16, under 510(k) number K090964.

Who is the listed applicant for BINAXNOX STAPHYLOCOCCUS AUREUS TEST?

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

What is the FDA product code for BINAXNOX STAPHYLOCOCCUS AUREUS TEST?

The FDA product code for BINAXNOX STAPHYLOCOCCUS AUREUS TEST is JWX.

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Related Devices (Code: JWX)

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.

K972030STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUSOxoid , Ltd.K964315REMEL STAPH LATEX KITRemel, L.P.K945538STAPHAUREX PLUS(TM)Murex Diagnostics LimitdK926173STAPH-A-LEX(TM) SYSTEMTrinity Laboratories, Inc.K923212SLIDEX STAPH-KITBiomerieux Vitek, Inc.K905617VISI-STAPHConnecticut Diagnostics, Ltd.

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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