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FDA 510(k)

CLEARVIEW EXACT PBP2A TEST, MODEL 891-000

K-Number: K091766 · 2010-02-24

ApplicantBinax, Inc.
Decision Date2010-02-24
Product CodeMYI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 is the device name listed in this FDA 510(k) record. The listed applicant is Binax, Inc.. It received FDA 510(k) clearance on 2010-02-24 under 510(k) number K091766. The device is classified under product code MYI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEARVIEW EXACT PBP2A TEST, MODEL 891-000?

CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 is a medical device that received FDA 510(k) clearance on 2010-02-24. The listed applicant is Binax, Inc.. The 510(k) number is K091766.

When did CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 receive FDA 510(k) clearance?

CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 received FDA 510(k) clearance on 2010-02-24, under 510(k) number K091766.

Who is the listed applicant for CLEARVIEW EXACT PBP2A TEST, MODEL 891-000?

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 CLEARVIEW EXACT PBP2A TEST, MODEL 891-000?

The FDA product code for CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 is MYI.

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Other records listing Binax, 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.

K090301BINAXNOW PBP2A TEST, MODEL 890-000K090964BINAXNOX STAPHYLOCOCCUS AUREUS TESTK091489CLEARVIEW ADVANCED STREP A , MODEL 737-430K083744BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010K092223MODIFICATION TO: BINAXNOW INFLUENZA A & B TESTK080003BINAXNOW G6PD TEST

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Related Devices (Code: MYI)

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.

K121905ALERE PBP2A TESTAlere Scarborough, Inc.K090301BINAXNOW PBP2A TEST, MODEL 890-000Binax, Inc.K062864MASTALEX -MRSA, MODEL RST501Mast Group , Ltd.K011710OXOID PBP2 1 LATEX AGGLUTINATION TESTOxoid , Ltd.K011400MRSA-SCREENDenka Seiken'SK010858VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTIONId Biomedical Corp.

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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