Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
510(k) Number K141757
FOIA Releasable 510(k) K141757
Device Name ALERE I STREP A
Applicant
Alere Scarborough, Inc.
10 Southgate Rd.
Scarborough,  ME  04074
Applicant Contact Angela Drysdale
Correspondent
Alere Scarborough, Inc.
10 Southgate Rd.
Scarborough,  ME  04074
Correspondent Contact Angela Drysdale
Regulation Number866.2680
Classification Product Code
PGX  
Subsequent Product Code
OOI  
Date Received06/30/2014
Decision Date 03/31/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-