Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ALERE PBP2A TEST

K-Number: K121905 · 2012-07-26

ApplicantAlere Scarborough, Inc.
Decision Date2012-07-26
Product CodeMYI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ALERE PBP2A TEST is the device name listed in this FDA 510(k) record. The listed applicant is Alere Scarborough, Inc.. It received FDA 510(k) clearance on 2012-07-26 under 510(k) number K121905. 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 ALERE PBP2A TEST?

ALERE PBP2A TEST is a medical device that received FDA 510(k) clearance on 2012-07-26. The listed applicant is Alere Scarborough, Inc.. The 510(k) number is K121905.

When did ALERE PBP2A TEST receive FDA 510(k) clearance?

ALERE PBP2A TEST received FDA 510(k) clearance on 2012-07-26, under 510(k) number K121905.

Who is the listed applicant for ALERE PBP2A TEST?

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

What is the FDA product code for ALERE PBP2A TEST?

The FDA product code for ALERE PBP2A TEST is MYI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Alere Scarborough, 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.

K190204ID NOW Influenza A & B 2K181853Alere BinaxNOW Influenza A & B Card 2, Alere ReaderK173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitK173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitK171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

View all 11 devices →

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.

K090301BINAXNOW PBP2A TEST, MODEL 890-000Binax, Inc.K091766CLEARVIEW EXACT PBP2A TEST, MODEL 891-000Binax, 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.

↑